Nuvicare-Allergy Relief Loratadine Tablets, 10 mg
<text/> <effectiveTime value="20250701"/> <subject> <manufacturedProduct> <manufacturedProduct> <code code="84324-027" codeSystem="2.16.840.1.113883.6.69"/> <name>Nuvicare-Allergy Relief Loratadine Tablets, 10 mg</name> <formCode code="C42998" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="TABLET"/> <asEntityWithGeneric> <genericMedicine> <name>loratadine</name> </genericMedicine> </asEntityWithGeneric> <ingredient classCode="ACTIB"> <quantity> <numerator unit="mg" value="10"/> <denominator unit="1" value="1"/> </quantity> <ingredientSubstance> <code code="7AJO3BO7QN" codeSystem="2.16.840.1.113883.4.9"/> <name>LORATADINE</name> <activeMoiety> <activeMoiety> <code code="7AJO3BO7QN" codeSystem="2.16.840.1.113883.4.9"/> <name>LORATADINE</name> </activeMoiety> </activeMoiety> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="EWQ57Q8I5X" codeSystem="2.16.840.1.113883.4.9"/> <name>LACTOSE MONOHYDRATE</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="70097M6I30" codeSystem="2.16.840.1.113883.4.9"/> <name>MAGNESIUM STEARATE</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="FZ989GH94E" codeSystem="2.16.840.1.113883.4.9"/> <name>povidone</name> </ingredientSubstance> </ingredient> <ingredient classCode="IACT"> <ingredientSubstance> <code code="O8232NY3SJ" codeSystem="2.16.840.1.113883.4.9"/> <name>STARCH, CORN</name> </ingredientSubstance> </ingredient> <asContent> <quantity> <numerator unit="1" value="100"/> <denominator unit="1" value="1"/> </quantity> <containerPackagedProduct> <code code="84324-027-01" codeSystem="2.16.840.1.113883.6.69"/> <formCode code="C43169" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="BOTTLE"/> </containerPackagedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20250701"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLCMBPRDTP" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C112160" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Type 0: Not a Combination Product" xsi:type="CE"/> </characteristic> </subjectOf> </asContent> </manufacturedProduct> <subjectOf> <marketingAct> <code code="C53292" codeSystem="2.16.840.1.113883.3.26.1.1"/> <statusCode code="active"/> <effectiveTime> <low value="20250701"/> </effectiveTime> </marketingAct> </subjectOf> <subjectOf> <approval> <id extension="ANDA214684" root="2.16.840.1.113883.3.150"/> <code code="C73584" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ANDA"/> <author> <territorialAuthority> <territory> <code code="USA" codeSystem="2.16.840.1.113883.5.28"/> </territory> </territorialAuthority> </author> </approval> </subjectOf> <subjectOf> <characteristic> <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C48348" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="ROUND" xsi:type="CE"/> </characteristic> </subjectOf> <subjectOf> <characteristic> <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/> <value xsi:type="ST">P;10</value> </characteristic> </subjectOf> <subjectOf> <characteristic> <code code="SPLCOLOR" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C48325" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="white" xsi:type="CE"/> </characteristic> </subjectOf> <subjectOf> <characteristic> <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value unit="mm" value="8" xsi:type="PQ"/> </characteristic> </subjectOf> <subjectOf> <characteristic> <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value value="1" xsi:type="INT"/> </characteristic> </subjectOf> <consumedIn> <substanceAdministration> <routeCode code="C38288" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="oral"/> </substanceAdministration> </consumedIn> </manufacturedProduct> </subject> </section> </component> <component> <section ID="Lf6b933ad-71b8-482d-9d9c-b3e376a0eb53"> <id root="67ab4bc3-5e4d-4758-a59b-74f69fb6b968"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <title> <content styleCode="italics"> <content styleCode="bold">Drug Facts</content> </content>
Active Ingredient (in each tablet) Loratadine, 10 mg 
Purpose Antihistamine
<content styleCode="bold">Uses</content> Temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Warnings Do not use if you ever have had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you  have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnanct or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away (1-800-222-1222)
Directions Adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours. 
Children under 6 years of age: Ask a doctor. 
Consumers with liver or kidney disease: Ask a doctor
Other Information Store between 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)  Protect from excessive moisture
Inactive ingredients Lactose monohydrate, magnesium stearate, povidone, maize starch, purified water.
Questions or comments? Call 1(718) 337-8733 or email: support@nuvicare.com
<text> <paragraph> <renderMultiMedia referencedObject="L7bda1cd6-5aaf-4ee8-aa79-0d76b92632ac"/> </paragraph> </text> <effectiveTime value="20250701"/> <component> <observationMedia ID="L7bda1cd6-5aaf-4ee8-aa79-0d76b92632ac"> <text>PL0270-00 NC Allergy Relief-Loratadine 100ct</text> <value mediaType="image/jpeg" xsi:type="ED"> <reference value="PL0270-00 NC Allergy Relief-Loratadine 100ct.jpg"/> </value> </observationMedia> </component> </section> </component> </structuredBody> </component> </document>