Neos Therapeutics Brands, LLC Aphena Pharma Solutions Halo Pharmaceuticals, Inc

Adzenys XR-ODT Amphetamine CROSPOVIDONE (15 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE FRUCTOSE SILICON DIOXIDE TRIETHYL CITRATE SUCRALOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED AMPHETAMINE AMPHETAMINE MANNITOL A6 Adzenys XR-ODT Amphetamine MANNITOL CROSPOVIDONE (15 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE FRUCTOSE SILICON DIOXIDE TRIETHYL CITRATE SUCRALOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED AMPHETAMINE AMPHETAMINE orange to light orange mottled A1 Adzenys XR-ODT Amphetamine MANNITOL CROSPOVIDONE (15 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE FRUCTOSE SILICON DIOXIDE TRIETHYL CITRATE SUCRALOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED AMPHETAMINE AMPHETAMINE A2 Adzenys XR-ODT Amphetamine MICROCRYSTALLINE CELLULOSE MANNITOL CROSPOVIDONE (15 MPA.S AT 5%) METHACRYLIC ACID SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE FRUCTOSE SILICON DIOXIDE TRIETHYL CITRATE SUCRALOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED AMPHETAMINE AMPHETAMINE A3 Adzenys XR-ODT Amphetamine MANNITOL CROSPOVIDONE (15 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE FRUCTOSE SILICON DIOXIDE TRIETHYL CITRATE SUCRALOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED AMPHETAMINE AMPHETAMINE A4 Adzenys XR-ODT Amphetamine MANNITOL CROSPOVIDONE (15 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE METHACRYLIC ACID SODIUM POLYSTYRENE SULFONATE CITRIC ACID MONOHYDRATE FRUCTOSE SILICON DIOXIDE TRIETHYL CITRATE SUCRALOSE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED AMPHETAMINE AMPHETAMINE A5

ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14) ]. Limitations of Use The use of ADZENYS XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4)]. ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. ( 1) Limitations of Use The use of ADZENYS XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4)

ADZENYS XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADZENYS XR-ODT, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing ADZENYS XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout ADZENYS XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)]. See full prescribing information for complete boxed warning. ADZENYS XR-ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ADZENYS XR-ODT, can result in overdose and death (5.1, 9.2, 10): Before prescribing ADZENYS XR-ODT, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

May be taken with or without food. Allow tablet to disintegrate in saliva then swallow. ( 2.2) Pediatric patients (ages 6 to 17 years): Starting dose is 6.3 mg once daily in the morning. Maximum dose is 18.8 mg once daily for patients 6 to 12 years, and 12.5 mg once daily for patients 13 to 17 years. ( 2.3) Adults: 12.5 mg once daily in the morning. ( 2.4) To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles. ( 2.5, 5.7)

Prior to treating patients with ADZENYS XR-ODT, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating ADZENYS XR-ODT [see Warnings and Precautions (5.9)].

The recommended starting dosage is 6.3 mg once daily in the morning. Increase in increments of 3.1 mg or 6.3 mg at weekly intervals. The maximum recommended dose is 18.8 mg daily for patients 6 to 12 years, and 12.5 mg daily for patients 13 to 17 years [see Use in Specific Populations (8.3), Clinical Studies (14) ].

The recommended dose is ADZENYS XR-ODT 12.5 mg daily.

ADZENYS XR-ODT may be taken orally with or without food. Individualize the dosage according to the therapeutic needs and response of the patient. ADZENYS XR-ODT should be taken as follows: The tablet should remain in the blister pack until the patient is ready to take it. The patient or caregiver should use dry hands to open the blister. Tear along the perforation, bend the blister where indicated and peel back the blister's labeled backing to take out the tablet. The tablet should not be pushed through the foil. As soon as the blister is opened, the tablet should be removed and placed on the patient's tongue. The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. The tablet will disintegrate in saliva so that it can be swallowed.

Patients taking ADDERALL XR may be switched to ADZENYS XR-ODT at the equivalent dose taken once daily [see Clinical Pharmacology (12.3) ]. Refer to Table 1 for equivalent doses of ADZENYS XR-ODT and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).

Table 1: Equivalent Doses of ADZENYS XR-ODT and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules

ADZENYS XR-ODT Amphetamine extended-release orally disintegrating tablets	3.1 mg	6.3 mg	9.4 mg	12.5 mg	15.7 mg	18.8 mg
ADDERALL XR Mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER)	5 mg	10 mg	15 mg	20 mg	25 mg	30 mg

If switching from any other amphetamine products, discontinue that treatment, and titrate with ADZENYS XR-ODT using the titration schedule [ see Dosage and Administration (2.3), (2.4) ]. Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see Warnings and Precautions (5.7) ].

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust ADZENYS XR-ODT dosage accordingly [see Drug Interactions (7.1) ].

ADZENYS XR-ODT is contraindicated: In patients known to be hypersensitive to amphetamine, or other components of ADZENYS XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2) ]. Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such a linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) , Drug Interactions 7.1]. Known hypersensitivity to amphetamine products or other ingredients in ADZENYS XR-ODT. ( 4) Use of monoamine oxidase inhibitor (MAOI) or within 14 days of the last MAOI dose. ( 4)

ADZENYS XR-ODT 3.1 mg Amphetamine extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A1 on one side) ADZENYS XR-ODT 6.3 mg Amphetamine extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A2 on one side) ADZENYS XR-ODT 9.4 mg Amphetamine extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A3 on one side) ADZENYS XR-ODT 12.5 mg Amphetamine extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A4 on one side) ADZENYS XR-ODT 15.7 mg Amphetamine extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A5 on one side) ADZENYS XR-ODT 18.8 mg Amphetamine extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A6 on one side) Extended-release orally disintegrating tablets: 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg ( 3)

. Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, or other serious cardiac disease. ( 5.2) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. ( 5.3) Psychiatric Adverse Reactions: Prior to initiating ADZENYS XR-ODT, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing ADZENYS XR-ODT. ( 5.4) Long-Term Suppression of Growth in Pediactric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.5) Peripheral Vasculopathy, including Raynaud's phenomenon: Careful observation for digital changes is necessary during ADZENYS XR-ODT treatment. Further clinical evaluation (e.g. rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. ( 5.6) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue ADZENYS XR-ODT and initiate supportive treatment. ( 5.7, 17) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating ADZENYS XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. (5.8)

ADZENYS XR-ODT has a high potential for abuse and misuse. The use of ADZENYS XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. ADZENYS XR-ODT can be diverted for nonmedical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2)]. Misuse and abuse of CNS stimulants, including ADZENYS XR-ODT, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ADZENYS XR-ODT, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store ADZENYS XR-ODT in a safe place, preferably locked, and instruct patients to not give ADZENYS XR-ODT to anyone else. Throughout ADZENYS XR-ODT treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid ADZENYS XR-ODT use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases.
Monitor all ADZENYS XR-ODT-treated patients for potential tachycardia and hypertension.

Exacerbation Pre-existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating ADZENYS XR-ODT treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or has a history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).

New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosages, may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in patients without prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in 0.1% of CNS stimulant-treated patients compared to 0% of placebo-treated patients. If such symptoms occur, conisder discontinuing ADZENYS XR-ODT.

ADZENYS XR-ODT is not approved for use and is not recommended in pediatric patients below 6 years of age [see Use in Specific Population (8.4)]. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in ADZENYS XR-ODT-treated pediatric patients treated with CNS stimulants. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.

CNS stimulants, including ADZENYS XR-ODT, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulants. Careful observation for digital changes is necessary during ADZENYS XR-ODT-treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for ADZENYS XRODT-treated patients who develop signs or symptoms of peripheral vasculopathy.

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1)]. The co-administration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase the risk with increased exposure to ADZENYS XR-ODT. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions (7.1)]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Concomitant use of ADZENYS XR-ODT with MAOI drugs is contraindicated [see Contraindications (4)]. Discontinue treatment with ADZENYS XR-ODT and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of ADZENYS XR-ODT with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate ADZENYS XR-ODT with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].
Before initiating ADZENYS XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor ADZENYS XR-ODT-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.

Medication errors, including substitution and dispensing errors, between ADZENYS XR-ODT and other amphetamine products could occur, leading to possible overdosage. To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see Dosage and Administration (2.5)].

The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2 , 9.3) ] Hypersensitivity to amphetamine, or other components of ADZENYS XR-ODT [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6) ] Serotonin Syndrome [ see Warnings and Precautions (5.7) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [ see Warnings and Precautions (5.8) ] Pediatric patients ages 6 to 12 years: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. ( 6.1) Pediatric patients ages 13 to 17 years: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. ( 6.1) Adults: Most common adverse reactions ≥5% and with a higher incidence than on placebo were dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics, Inc. at 1-888-319-1789 or http://www.adzenysxrodt.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ADZENYS XR-ODT has been established from adequate and well-controlled studies of single-entity amphetamine product extended-release (MAS ER) capsules [see Clinical Studies (14) ]. The adverse reactions of MAS ER capsules in these adequate and well-controlled studies are described below. The premarketing development program for MAS ER included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12 years) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40).

The following adverse reactions are from clinical trials and spontaneous postmarketing reports of other amphetamine products in pediatric patients and adults with ADHD. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular: Palpitations, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System: Restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, paresthesia (including formication), motor and verbal tics. Eye Disorders: Vision blurred, mydriasis. Gastrointestinal: Unpleasant taste, constipation, intestinal ischemia, other gastrointestinal disturbances. Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported. Endocrine: Impotence, change in libido, frequent or prolonged erections. Skin: Alopecia. Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis. Psychiatric Disorders: dermatillomania, bruxism. Vascular Disorders: Raynaud's phenomenon.

Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents can increase amphetamine blood levels. Adjust ADZENYS XR-ODT dosage accordingly. ( 7.1 )

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Table 5: Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)
Clinical Impact	MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention	Do not administer ADZENYS XR-ODT during or within 14 days following the administration of MAOI [see Contraindications (4) ].
Serotonergic Drugs
Clinical Impact	The concomitant use of ADZENYS XR-ODT and serotonergic drugs increases the risk of serotonin syndrome.
Intervention	Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ADZENYS XR-ODT initiation or dosage increase. If serotonin syndrome occurs, discontinue ADZENYS XR-ODT and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.7)] .
Alkalinizing Agents
Clinical Impact	Increase blood levels and potentiate the action of amphetamine.
Intervention	Co-administration of ADZENYS XR-ODT and gastrointestinal alkalinizing agents should be avoided.
Acidifying Agents
Clinical Impact	Lower blood levels and efficacy of amphetamines.
Intervention	Increase dose based on clinical response.
Tricyclic Antidepressants
Clinical Impact	May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.
Intervention	Monitor frequently and adjust or use alternative therapy based on clinical response.

. Pregnancy: May cause fetal harm. ( 8.1) Lactation: Breastfeeding not recommended. ( 8.2)

Risk Summary Based on limited case reports in published literature, amphetamine (d- or d, l-) is present in human milk at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. There are no reports of adverse effects on the breastfed infant. Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown. It is possible that large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established. Because of the potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during treatment with ADZENYS XR-ODT.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in women exposed to ADHD medications, including ADZENYS XR-ODT, during pregnancy. Healthcare providers are encouraged to advise patients to register by contacting the National Pregnancy Registry for ADHD Medication at 1-866-961-2388 or online at www.womensmentalhealth.org/pregnancyregistry. Risk Summary Available data from epidemiologic studies and postmarketing reports on the use of amphetamine in pregnant women over decades of use have not identified a drug-associated risk of major birth defects or miscarriage. Neonates exposed to amphetamine in utero are at risk for withdrawal symptoms following delivery. Adverse pregnancy outcomes including premature delivery and low birth weight have been seen in infants born to mothers taking amphetamines during pregnancy (see Clinical Considerations). No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis. However, in a pre- and post-natal development study, amphetamine (d- to l- ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as ADZENYS XR-ODT, cause vasoconstriction and thereby may decrease placental perfusion. In addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. Data Animal Data Amphetamine, in the enantiomer ratio present in ADZENYS XR-ODT, (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) for adolescents of 12.5 mg/day (as base), on a mg/m2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a mg/m2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1, the same as in ADZENYS XR-ODT) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of 12.5 mg/day (as base), on a mg/m2 basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks post-weaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

ADZENYS XR-ODT has not been studied in the geriatric population.

The safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration [see Adverse Reactions (6.1), Clinical Pharmacology (12), Clinical Studies (14) ]. The safety and efficacy of ADZENYS XR-ODT in pediatric patients less than 6 years have not been established. In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

ADZENYS XR-ODT contains amphetamine, a Schedule II controlled substance.

ADZENYS XR-ODT has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings and Precautions (5.1)]. ADZENYS XR-ODT can be diverted for non-medical use into illicit channels or distribution.
Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.
Misuse and abuse of amphetamine may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including ADZENYS XRODT, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Physical Dependence
ADZENYS XR-ODT may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including ADZENYS XR-ODT include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance
ADZENYS XR-ODT may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

ADZENYS XR-ODT (amphetamine extended-release orally disintegrating tablet) contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant. The labeled strengths reflect the amount of amphetamine base in ADZENYS XR-ODT whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products. Structural Formula: C 9H 13N MW 135.21 ADZENYS XR-ODT is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing. ADZENYS XR-ODT also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350. Structural Formula

Clinical Effects of Overdose
Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucination. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur.
• Life-threatening hyperthermia (temperatures greater than 104ºF) and rhabdomyolysis may develop. Overdose Management
Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of ADZENYS XR-ODT should be considered when treating patients with overdose. Damphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Acute administration of high doses of amphetamine (d- or d, l-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance of these findings to humans is unknown.

The safety and efficacy of ADZENYS XR-ODT has been established based on adequate and well-controlled studies of mixed salts of a single-entity amphetamine product extended-release capsules in the treatment of ADHD. Below is a description of the results of the adequate and well-controlled studies of mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER) in the treatment of ADHD.

Storage Store at 20°C to 25º C (68°F to 77º F). Excursions permitted to 15-30º C (59-86º F) [see USP Controlled Room Temperature] Store ADZENYS XR-ODT blister packages in the rigid, plastic travel case provided after removal from the carton. To obtain additional travel cases, patients and health care professionals can call Neos Therapeutics, Inc., at 1-888-236-6816.

How Supplied ADZENYS XR-ODT 3.1 mg extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A1 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-005-30 ADZENYS XR-ODT 6.3 mg extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A2 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-010-30 ADZENYS XR-ODT 9.4 mg extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A3 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-015-30 ADZENYS XR-ODT 12.5 mg extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A4 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-020-30 ADZENYS XR-ODT 15.7 mg extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A5 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-025-30 ADZENYS XR-ODT 18.8 mg extended release orally disintegrating tablet: round, orange to light orange mottled (debossed A6 on one side), carton containing 5 blister cards of 6 tablets each, for a total of 30 tablets, NDC 70165-030-30

MEDICATION GUIDE ADZENYS XR-ODT (add-ZEN-iss) amphetamine extended-release orally disintegrating tablets, CII
This Medication Guide has been approved by the U.S. Food and Drug Administration.			09/2025
What is the most important information I should know about ADZENYS XR-ODT? ADZENYS XR-ODT may cause serious side effects, including: Abuse, misuse, and addiction. ADZENYS XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ADZENYS XR-ODT, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ADZENYS XR-ODT or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with ADZENYS XR-ODT and will monitor you or your child during treatment. ADZENYS XR-ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give ADZENYS XR-ODT to anyone else. See “ What is ADZENYS XR-ODT?” for more information. Keep ADZENYS XR-ODT in a safe place and properly dispose of any unused medicine. See “ How should I store ADZENYS XR-ODT?” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting ADZENYS XR-ODT. Tell your healthcare provider if you or your child has any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking ADZENYS XR-ODT. Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ADZENYS XR-ODT. Mental (Psychiatric) problems: All Patients new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking ADZENYS XR-ODT, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What is ADZENYS XR-ODT? ADZENYS XR-ODT is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). ADZENYS XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. ADZENYS XR-ODT is not recommended for use in children under 6 years of age with ADHD. ADZENYS XR-ODT is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep ADZENYS XR-ODT in a safe place to prevent it from theft. Never give your ADZENYS XR-ODT to anyone else, because it may harm them. Selling or giving away ADZENYS XR-ODT may harm others and is against the law.
Who should not take ADZENYS XR-ODT? ADZENYS XR-ODT should not be taken if you or your child: are allergic to amphetamine, or any of the ingredients in ADZENYS XR-ODT. See the end of this Medication Guide for a complete list of ingredients in ADZENYS XR-ODT. are taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI.
What should I tell my healthcare provider before taking ADZENYS XR-ODT? ADZENYS XR-ODT may not be right for you or your child. Before starting ADZENYS XR-ODT, tell your or your child’s healthcare provider about all health conditions (or a family history of) including: heart problems, heart disease, heart defects, or high blood pressure mental problems including psychosis, mania, bipolar illness, or depression circulation problems in fingers and toes Tell your healthcare provider: if you or your child have kidney problems. Your healthcare provider may lower the dose. have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome. if you or your child are pregnant, or plan to become pregnant. It is not known if ADZENYS XR-ODT will harm your unborn baby. • There is a pregnancy registry for women who are exposed to ADZENYS XR-ODT during pregnancy. The purpose of the registry is to collect information about the health of females exposed to ADZENYS XR-ODT and their babies. If you or your child becomes pregnant during treatment with ADZENYS XR-ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/. if you or your child is breastfeeding or plan to breastfeed. ADZENYS XR-ODT passes into breast milk. You should not breastfeed while you are taking ADZENYS XR-ODT. Talk to your healthcare provider about the best way to feed the baby during treatment with ADZENYS XR-ODT. Tell your healthcare provider about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADZENYS XR-ODT and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking ADZENYS XR-ODT. Your healthcare provider will decide whether ADZENYS XR-ODT can be taken with other medicines. Especially tell your healthcare provider if you or your child takes: anti-depression medicines including MAOIs Know the medicines that you or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist. Do not start any new medicine while taking ADZENYS XR-ODT without talking to your healthcare provider first.
How should ADZENYS XR-ODT be taken? Take ADZENYS XR-ODT exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child. Take ADZENYS XR-ODT 1 time each day in the morning. Leave the tablet in the blister pack until you are ready to take or give it. Use dry hands to open the blister pack. Tear along the perforation, bend the blister where indicated and peel back the blister's labeled backing to take out the tablet. Do not push the tablet through the foil. Place the tablet on the tongue. Take ADZENYS XR-ODT as soon as you open the blister pack. The tablet will dissolve in your mouth (saliva) so that it can be swallowed. Do not crush or chew. ADZENYS XR-ODT can be taken with or without food. Your healthcare provider may do regular checks of your or your child’s blood, heart, and blood pressure while taking ADZENYS XR-ODT. Children should have their height and weight checked often while taking ADZENYS XR-ODT. ADZENYS XR-ODT treatment may be stopped if a problem is found during these check-ups. If you or your child take too much ADZENYS XR-ODT, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
What should I avoid while taking ADZENYS XR-ODT? drinking alcohol
What are possible side effects of ADZENYS XR-ODT? ADZENYS XR-ODT can cause serious side effects, including: See " What is the most important information I should know about ADZENYS XR-ODT?" for information on reported heart and mental problems. slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with ADZENYS XR-ODT. Your healthcare provider may stop your child’s ADZENYS XR-ODT treatment if they are not growing or gaining weight as expected. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]: fingers or toes may feel numb, cool, painful fingers or toes may change from pale, to blue, to red Tell your healthcare provider if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your healthcare provider right away if you have or your child has any unexplained wounds appearing on fingers or toes while taking ADZENYS XR-ODT. New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with ADZENYS XR-ODT. Common side effects of ADZENYS XR-ODT include decreased appetite and problems sleeping . Common side effects of ADZENYS XR-ODT in children 6 to 12 years of age also include:
stomach pain nervousness	extreme mood change nausea	vomiting fever
Common side effects of ADZENYS XR-ODT in children 13 to 17 years of age also include:
stomach pain	weight loss
Common side effects of ADZENYS XR-ODT in adults also include:
dry mouth nausea dizziness weakness	headache anxiety fast heart beat urinary tract infections	weight loss restlessness diarrhea
Talk to your doctor if you or your child have side effects that are bothersome or do not go away. These are not all the possible side effects ADZENYS XR-ODT. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store ADZENYS XR-ODT? Store ADZENYS XR-ODT at room temperature between 68° F to 77° F (20° C to 25° C). Store ADZENYS XR-ODT in a safe place, like a locked cabinet. Store ADZENYS XR-ODT in the blister packaging until you are ready to take or give it. Store ADZENYS XR-ODT blister packages in the hard plastic travel case provided after removal from the carton. Dispose of remaining, unused, or expired ADZENYS XR-ODT by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix ADZENYS XR-ODT with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away ADZENYS XR-ODT in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep ADZENYS XR-ODT and all medicines out of the reach of children.
General information about the safe and effective use of ADZENYS XR-ODT Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use ADZENYS XR-ODT for a condition for which it has not been prescribed. Do not give ADZENYS XR-ODT to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about ADZENYS XR-ODT. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ADZENYS XR-ODT that is written for healthcare professionals. For more information about ADZENYS XR-ODT or to get a plastic travel case contact Neos Therapeutics, Inc. at 1-888-236-6816 or go to www.adzenysxrodt.com.
What are the ingredients in ADZENYS XR-ODT? Active Ingredients: Amphetamine Inactive Ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose,Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350. Manufactured for Neos Therapeutics Brands LLC, Denver, CO 80237. ADZENYS XR-ODT is registered in the US Patent and Trademark Office© 2016 Neos Therapeutics, Inc.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

NDC 70165-005-30 Contains:

30 Tablets (5 x 6-count blister cards)

Travel Case Rx Only Adzenys XR-ODT™ CII

Amphetamine Extended-Release

Orally Disintegrating Tablets Do not crush or chew tablets Each tablet contains 3.1 mg of amphetamine

(equivalent to that in a 5 mg strength mixed salts

of a single-entity amphetamine product) 3.1 mg NEOS™

Therapeutics PHARMACIST: Dispense the enclosed Medication Guide to each patient. adzenys xr-odt 3.1 mg

NDC 70165-010-30 Contains:

30 Tablets (5 x 6-count blister cards)

Travel Case Rx Only Adzenys XR-ODT™ CII

Amphetamine Extended-Release

Orally Disintegrating Tablets Do not crush or chew tablets Each tablet contains 6.3 mg of amphetamine

(equivalent to that in a 10 mg strength mixed salts

of a single-entity amphetamine product) 6.3 mg NEOS™

Therapeutics PHARMACIST: Dispense the enclosed Medication Guide to each patient. adzenys xr-odt 6.3 mg

NDC 70165-015-30 Contains:

30 Tablets (5 x 6-count blister cards)

Travel Case Rx Only Adzenys XR-ODT™ CII

Amphetamine Extended-Release

Orally Disintegrating Tablets Do not crush or chew tablets Each tablet contains 9.4 mg of amphetamine

(equivalent to that in a 15 mg strength mixed salts

of a single-entity amphetamine product) 9.4 mg NEOS™

Therapeutics PHARMACIST: Dispense the enclosed Medication Guide to each patient. adzenys xr-odt 9.4 mg

NDC 70165-020-30 Contains:

30 Tablets (5 x 6-count blister cards)

Travel Case Rx Only Adzenys XR-ODT™ CII

Amphetamine Extended-Release

Orally Disintegrating Tablets Do not crush or chew tablets Each tablet contains 12.5 mg of amphetamine

(equivalent to that in a 20 mg strength mixed salts

of a single-entity amphetamine product) 12.5 mg NEOS™

Therapeutics PHARMACIST: Dispense the enclosed Medication Guide to each patient. adzenys xr-odt 12.5 mg

NDC 70165-025-30 Contains:

30 Tablets (5 x 6-count blister cards)

Travel Case Rx Only Adzenys XR-ODT™ CII

Amphetamine Extended-Release

Orally Disintegrating Tablets Do not crush or chew tablets Each tablet contains 15.7 mg of amphetamine

(equivalent to that in a 25 mg strength mixed salts

of a single-entity amphetamine product) 15.7 mg NEOS™

Therapeutics PHARMACIST: Dispense the enclosed Medication Guide to each patient. adzenys xr-odt 15.7 mg

NDC 70165-030-30 Contains:

30 Tablets (5 x 6-count blister cards)

Travel Case Rx Only Adzenys XR-ODT™ CII

Amphetamine Extended-Release

Orally Disintegrating Tablets Do not crush or chew tablets Each tablet contains 18.8 mg of amphetamine

(equivalent to that in a 30 mg strength mixed salts

of a single-entity amphetamine product) 18.8 mg NEOS™

Therapeutics PHARMACIST: Dispense the enclosed Medication Guide to each patient. adzenys xr-odt 18.8 mg