FDA Label for Allergy Relief

View Indications, Usage & Precautions

Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Twin Med Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Caplet)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:  
  •      o runny nose

         o sneezing

         o itchy, watery eyes

         o itchy nose or throat

    • temporarily relieves these symptoms of the common cold:
    •     o runny nose
          o sneezing


Warnings



do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
  • Ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma 
    • a breathing problem such as emphysema or chronic bronchitis
    • Ask your doctor or pharmacist before use if youaretaking sedatives or tranquilizers

      When using this product

      • marked drowsiness may occur
      • alcohol, sedatives and tranquilizers may increase drowsiness
      • avoid alcoholic beverages
      • be careful when driving a motor vehicle or operating machinery
      • excitability may occur, especially in children

If Pregnant 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 (1-800-222-1222) right away.


Directions



  • take every 4 to 6 hours, or as directed by a doctor
  • do not take not more than 6 times in 24 hours
  • adults and children 12 years  and over: 1 or 2 tablets
  • children 6 to under 12 years: 1 tablet
  • children under 6 years: do not use

Other Information



  • protect from moisture
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Questions ?



call toll-free 1-844-912-4012


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