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<subjectOf> <characteristic classCode="OBS"> <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="CV"> <originalText>White to Off-white</originalText> </value> </characteristic> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLSHAPE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value code="C48347" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="RECTANGLE" xsi:type="CV"> <originalText>off-rectangular</originalText> </value> </characteristic> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLSIZE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value unit="mm" value="9" xsi:type="PQ"/> </characteristic> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLSCORE" codeSystem="2.16.840.1.113883.1.11.19255"/> <value value="2" xsi:type="INT"/> </characteristic> </subjectOf> <subjectOf> <characteristic classCode="OBS"> <code code="SPLIMPRINT" codeSystem="2.16.840.1.113883.1.11.19255"/> <value xsi:type="ST">X;2;0</value> </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="Section_0"> <id root="97e2af6b-319c-4cb6-8b9c-140922614e7b"/> <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/> <text> <paragraph> <content styleCode="bold"> <content styleCode="italics"> <br/> Drug Facts</content> </content> </paragraph> </text> <effectiveTime value="20250210"/> </section> </component> <component> <section ID="Section_1"> <id root="d3e0c6cb-2137-4004-ac2a-b627b7f4c200"/> <code code="55106-9" codeSystem="2.16.840.1.113883.6.1" displayName="OTC - ACTIVE INGREDIENT SECTION"/> <title>Active ingredient (in each tablet)


          Purpose
          
            

             Antihistamine


      
        
          
          
          Uses
          
            reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
          
          
        

      
      
        
          
          
          Warnings
          
            
              Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:
            

            
              trouble swallowing
              dizziness or loss of consciousness
              swelling of tongue 
              swelling in or around mouth
              trouble speaking
              drooling
              wheezing or problems breathing
            
            These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

              

              Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.
            

          
          
        

      
      
        
          
          
          Do not use
          
            
              to prevent hives from any known cause such as:     
                  foods 
                  insect stings
                  medicines
                  latex or rubber gloves
                
              
            
            because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
            
              if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
            
          
          
        

      
      
        
          
          
          Ask a doctor before use if you have
          
            
              liver or kidney disease. Your doctor should determine if you need a different dose.
              hives that are an unusual color, look bruised or blistered
              hives that do not itch
            
          
          
        

      
      
        
          
          
          Ask a doctor or pharmacist before use if you are
          
            taking tranquilizers or sedatives.
          
          
        

      
      
        
          
          
          When using this product
          
            
              drowsiness may occur
              avoid alcoholic drinks
              alcohol, sedatives, and tranquilizers may increase drowsiness
              be careful when driving a motor vehicle or operating machinery
            
          
          
        

      
      
        
          
          
          Stop use and ask a doctor if
          
            
              an allergic reaction to this product occurs. Seek medical help right away.
              symptoms do not improve after 3 days of treatment.
              the hives have lasted more than 6 weeks.
            
          
          
        

      
      
        
          
          
          If pregnant or breast-feeding:
          
            
              if breast-feeding: not recommended
              if pregnant: 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
          
            

            
              For  5 mg:
            
            
              
                
                
              
              
                
                  adults and children 6 years and over

                  
                  1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours

                  
                
                
                  adults 65 years and over

                  
                  1 tablet once a day; do not take 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

                  
                
              
            
            

            
              For 10 mg:
            
            
              
                
                
              
              
                
                  adults and children 6 years and over

                  
                  one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

                  
                
                
                  adults 65 years and over

                  
                  ask a doctor

                  
                
                
                  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)
              
                TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.
              
            
          
          
        

      
      
        
          
          
          Inactive ingredients
          
            

             colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
          
          
        

      
      
        
          
          
          Questions?
          
            call 1-855-274-4122

                
                  
 Important: Read all product information before using. Keep this carton for important information.

                
              
              
 Distributed by:

              AUROHEALTH LLC

              279 Princeton-Hightstown Road
 East Windsor, NJ 08520
          
          
        

      
      
        
          
          
          PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)
          
            
              AUROHEALTH

                
 NDC 58602-446-09

                
 *Compare to the active
 ingredient of Zyrtec^®
                

                

                HIVES RELIEF
                

                
 Cetirizine Hydrochloride Tablets USP
 5 mg

                
 Antihistamine

                Original Prescription Strength

                
                

                HIVES RELIEF
                
 24 Hour relief        Reduces
                                 Hives
 30
 Tablets                    Reduces Itching
 5 mg each                Due to Hives
                                    

                

                
                

                

              
            
          
          
          
            
              PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)
              
                
              
            
          
        

      
      
        
          
          
          PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)
          
            
              
                AUROHEALTH

                  
 NDC 58602-446-21

                  
 *Compare to the active
 ingredient of Zyrtec^®
                  

                  

                  HIVES RELIEF
                  

                  
 Cetirizine Hydrochloride Tablets USP
 5 mg

                  
 Antihistamine

                
                Original Prescription Strength

                
                

                
                  HIVES RELIEF
                  
 24 Hour relief        Reduces
                                 Hives
 100
 (10x10's)
 Unit dose Tablets         Reduces Itching
 5 mg each                      Due to Hives
                

                

                
                

              
            
          
          
          
            
              PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)
              
                
              
            
          
        

      
      
        
          
          
          PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)
          
            
              
                AUROHEALTH

                  
 NDC 58602-447-09

                  
 *Compare to the active
 ingredient of Zyrtec^®
                  

                  

                  HIVES RELIEF
                  

                  
 Cetirizine Hydrochloride Tablets USP 10 mg

                  
 Antihistamine

                
                Original Prescription Strength

                
                

                
                  HIVES RELIEF
                  
 24 Hour relief        Reduces
                                 Hives
 30
 Tablets                                            Reduces Itching
 10 mg each    Actual Size               Due to Hives
              
            
            

            

            
            

          
          
          
            
              PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)
              
                
              
            
          
        

      
      
        
          
          
          PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)
          
            
              
                AUROHEALTH

                  
 NDC 58602-447-21

                  
 *Compare to the active
 ingredient of Zyrtec^®
                  

                  

                  HIVES RELIEF
                  

                  
 Cetirizine Hydrochloride Tablets USP 10 mg

                  
 Antihistamine

                
                Original Prescription Strength

                
                

                
                  HIVES RELIEF
                  
 24 Hour relief        Reduces
                                 Hives

                  
 100 Tablets                   
 (10x10 Unit-dose)                                   Reduces Itching            
 10 mg each                   Actual Size         Due to Hives
                

                

                
                

                

                

              
            
          
          
          
            
              PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
adults 65 years and over	1 tablet once a day; do not take 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

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor