CETIRIZINE HYDROCHLORIDE TABLETS<br/>


  CETIRIZINE HYDROCHLORIDE TABLETS<br/>
  
  
  
  
  
    
    
      
        
        Amneal Pharmaceuticals LLC
        
          
            
              
                
                Amneal Pharmaceuticals of New York, LLC
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
            
          
        
      
    
  
  
    
      
        
          
          
          
          
            
              
                
                Cetirizine HydrochlorideHives Relief
                
                
                
                  
                    Cetirizine
                  
                
                
                  
                    
                    
                  
                  
                    
                    CETIRIZINE HYDROCHLORIDE
                    
                      
                        
                        CETIRIZINE
                      
                    
                  
                
                
                  
                    
                    LACTOSE MONOHYDRATE
                  
                
                
                  
                    
                    MAGNESIUM STEARATE
                  
                
                
                  
                    
                    POLYVINYL ALCOHOL, UNSPECIFIED
                  
                
                
                  
                    
                    POLYETHYLENE GLYCOL, UNSPECIFIED
                  
                
                
                  
                    
                    POVIDONE
                  
                
                
                  
                    
                    STARCH, CORN
                  
                
                
                  
                    
                    TALC
                  
                
                
                  
                    
                    TITANIUM DIOXIDE
                  
                
                
                  
                    
                    
                  
                  
                    
                    
                    
                      
                        
                        
                      
                      
                        
                        
                      
                      
                        
                          
                          
                          
                            
                          
                        
                      
                    
                  
                  
                    
                      
                      
                    
                  
                
                
                  
                    
                    
                  
                  
                    
                    
                  
                  
                    
                      
                      
                    
                  
                  
                    
                      
                      
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                  
                    
                  
                
              
              
                
                  
                  
                
              
              
                
                  
                  IP;45
                
              
              
                
                  
                  
                
              
              
                
                  
                  
                
              
              
                
                  
                  
                
              
              
                
                  
                
              
            
          
        

      
      
        
          
          
          
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                (in each tablet) 
              
            
            Cetirizine HCl, USP 5 mg
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">PURPOSE
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            Antihistamine
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">INDICATIONS AND USAGE
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            Relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">WARNINGS
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              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.
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">DO NOT USE
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              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 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 its ingredients or to an antihistamine containing hydroxyzine.
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">ASK DOCTOR
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              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
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">ASK DOCTOR/PHARMACIST
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              Ask a doctor of pharmacist before use if you are taking tranquilizers or sedatives.
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">WHEN USING
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              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
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">STOP USE
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              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
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">PREGNANCY OR BREAST FEEDING
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              If pregnant or breast-feeding:
            • if breast-feeding: not recommended
            • if pregnant: ask a health professional before use.
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">KEEP OUT OF REACH OF CHILDREN
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              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)
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">DIRECTIONS</content>
          
          
            
              
              
              
                
                  
                  
                
                
                  Adults and children 6years and over
                  1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
                
                
                  Adults 65years and over
                  1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
                
                
                  Children under 6 years of age
                  ask a doctor
                
                
                  Consumers with liver or kidney disease
                  ask a doctor
                
              
            
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">OTHER INFORMATION
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                Other information
              
            
            • store between 20° to 25°C (68° to 77°F)
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">INACTIVE INGREDIENTS</content>
          
          
            
              
                Inactive Ingredients
              
            
            lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.
          
          
        

      
      
        
          
          
          
            <content styleCode="bold">OTC - QUESTIONS
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                Questions or Comments?
              
            
            
              Call 1-877-835-5472
            
            
              Monday through Friday 9AM - 5PM EST.
            
          
          
        

      
      
        
          
          
          
          <text>
            <paragraph>Distributed by:  <br/>
              <content styleCode="bold">Amneal Pharmaceuticals LLC<br/>
              </content>Bridgewater, NJ 08807</paragraph>
            <paragraph>Rev. 08-2023-01</paragraph>
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Adults and children 6years and over	1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
Adults 65years and over	1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
Children under 6 years of age	ask a doctor
Consumers with liver or kidney disease	ask a doctor