Non-Drowsy Daytime Severe Cold Multi-Symptom


   Non-Drowsy Daytime Severe Cold Multi-Symptom
   
   
   
   
      
      
         
            
            Spirit Pharmaceuticals LLC
         
      
   
   
      
         
            
               
               
               
               
                  
                     
                        
                        Non-Drowsy Daytime Severe Cold Multi-Symptom
                        
                        
                           
                              Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr and Guaifenesin
                           
                        
                        
                           
                              
                              CROSCARMELLOSE SODIUM
                           
                        
                        
                           
                              
                              D&C YELLOW NO. 10
                           
                        
                        
                           
                              
                              MAGNESIUM STEARATE
                           
                        
                        
                           
                              
                              MICROCRYSTALLINE CELLULOSE
                           
                        
                        
                           
                              
                              POLYETHYLENE GLYCOL 400
                           
                        
                        
                           
                              
                              POLYVINYL ALCOHOL, UNSPECIFIED
                           
                        
                        
                           
                              
                              STARCH, CORN
                           
                        
                        
                           
                              
                              TALC
                           
                        
                        
                           
                              
                              TITANIUM DIOXIDE
                           
                        
                        
                           
                              
                              
                           
                           
                              
                              ACETAMINOPHEN
                              
                                 
                                    
                                    ACETAMINOPHEN
                                 
                              
                           
                        
                        
                           
                              
                              
                           
                           
                              
                              DEXTROMETHORPHAN HYDROBROMIDE
                              
                                 
                                    
                                    DEXTROMETHORPHAN
                                 
                              
                           
                        
                        
                           
                              
                              
                           
                           
                              
                              GUAIFENESIN
                              
                                 
                                    
                                    GUAIFENESIN
                                 
                              
                           
                        
                        
                           
                              
                              
                           
                           
                              
                              PHENYLEPHRINE HYDROCHLORIDE
                              
                                 
                                    
                                    PHENYLEPHRINE
                                 
                              
                           
                        
                        
                           
                              
                              POVIDONE
                           
                        
                        
                           
                              
                              
                           
                           
                              
                              
                              
                                 
                                    
                                    
                                 
                                 
                                    
                                    
                                 
                                 
                                    
                                       
                                       
                                       
                                          
                                       
                                    
                                 
                              
                           
                           
                              
                                 
                                 
                              
                           
                        
                     
                     
                        
                           
                           
                           
                              
                                 
                                    
                                 
                              
                           
                        
                     
                     
                        
                           
                           
                           
                              
                           
                        
                     
                     
                        
                           
                           
                              
                           
                        
                     
                     
                        
                           
                           ET32
                        
                     
                     
                        
                           
                           
                        
                     
                     
                        
                           
                           
                              
                           
                        
                     
                     
                        
                           
                           
                        
                     
                     
                        
                           
                        
                     
                  
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Active ingredients (in each caplet)</content>
                  </content>
               
               
                  Acetaminophen 325 mg
       
 
  
Dextromethorphan HBr 10 mg
       
 
  
Guaifenesin 200 mg
       
 
  
Phenylephrine HCl 5 mg
      

 
               
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Purpose</content>
                  </content>
               
               
                  Pain reliever/fever reducer
       
 
  
Cough suppressant
       
 
  
Expectorant
       
 
  
Nasal decongestant
      

 
               
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Uses</content>
                  </content>
               
               
                  
                     temporarily relieves these common cold and flu symptoms:
        
  
   
                           sore throat 
                           cough
                           nasal congestion
                           headache
                           minor aches and pains
                        
                     
                     helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
                     temporarily reduces fever
                  
               
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Warnings</content>
                  </content>
               
               
                  
                     Liver warning: This product contains acetaminophen.
       
 
  
The maximum daily dose of this product is 10 caplets
       
 
  
(3,250 mg) in 24 hours. Severe liver damage may occur if you take
      

 
                  
                     more than 4,000 mg of acetaminophen in 24 hours
                     with other drugs containing acetaminophen
                     3 or more alcoholic drinks every day while using this product
                  
                  
                     Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
      

 
                  
                     skin reddening
                     blisters
                     rash
                  
                  If a skin reaction occurs, stop use and seek medical help right away.
                  
                     Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied for followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
      

 
               
               
               
                  
                     
                     
                     
                        <content styleCode="bold">Do not use</content>
                     
                     
                        
                           with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
                           if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
                           if you have ever had an allergic reaction to this product or any of its ingredients
                        
                     
                     
                  

               
               
                  
                     
                     
                     
                        <content styleCode="bold">Ask a doctor before use if you have
         
 
  <br/>
                        </content>
                     
                     
                        
                           heart disease
                           liver disease
                           diabetes
                           persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
                           thyroid disease
                           cough that occurs with too much phlegm (mucus)
                           difficulty in urination due to enlargement of the prostate gland
                           high blood pressure
                        
                     
                     
                  

               
               
                  
                     
                     
                     
                        <content styleCode="bold">Ask a doctor or pharmacist before use if you are
         
 
  <br/>
                        </content>
                     
                     
                        taking the blood thinning drug warfarin.
                     
                     
                  

               
               
                  
                     
                     
                     
                        <content styleCode="bold">When using this product</content>
                     
                     
                        
                           do not exceed recommended dosage.
                        
                     
                     
                  

               
               
                  
                     
                     
                     
                        <content styleCode="bold">Stop use and ask a doctor if</content>
                     
                     
                        
                           nervousness, dizziness, or sleeplessness occur
                           pain, nasal congestion, or cough gets worse or lasts more than 7 days
                           new symptoms occur
                           fever gets worse or lasts more than 3 days
                           redness or swelling is present
                           cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
                        
                     
                     
                  

               
               
                  
                     
                     
                     
                        <content styleCode="bold">If pregnant or breast-feeding,</content>
                     
                     
                        ask a health professional before use.
                     
                     
                  

               
               
                  
                     
                     
                     
                        <content styleCode="bold">Keep out of reach of children.</content>
                     
                     
                        In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
                     
                     
                  

               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Directions</content>
                  </content>
               
               
                  
                     
                        do not take more than directed
                     
                     adults and children 12 years and over
        
  
   
                           take 2 caplets every 4 hours
                           swallow whole - do not crush, chew, or dissolve
                           do not take more than 10 caplets in 24 hours
                        
                     
                     children under 12 years: ask a doctor
                  
               
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Other information</content>
                  </content>
               
               
                  
                     
                  
                  
                     store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
                  
               
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Inactive ingredients</content>
                  </content>
               
               
                  D&C Yellow#10, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide
                  *may contain this ingredient
               
               
            

         
         
            
               
               
               
                  <content styleCode="bold">
                     <content styleCode="italics">Questions or comments? </content>
                  </content>
               
               
                  
                     1-888-333-9792
                  
               
               
            

         
         
            
               
               
               PRINCIPAL DISPLAY PANEL
               
                  DAYTIME
                  NON-DROWSY
                  SEVERE
       
 
  
COLD
       
 
  
MULTI-SYMPTOM
       
 
  
• Acetaminophen - Pain Reliever / Fever Reducer
       
 
  
• Dextromethorphan HBr - Cough Suppressant
       
 
  
• Guaifenesin- Expectorant
       
 
  
• Phenylephrine HCl - Nasal Decongestant
      

 
                  12 caplets
                  
                     
                  
               
               
               
                  
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