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  5. Label Information: Diphenhydramine Hydrochloride

FDA Label for Diphenhydramine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. IF PREGNANT OR BREAST-FEEDING,
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Bi-mart. 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 Tablet)



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 of the 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

    • glaucoma 
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to  enlargement of the prostate gland

      • Ask a doctor or pharmacist before use if youaretaking sedatives or tranquilizers

      When using this product

      • marked drowsiness may occur
      • avoid alcoholic drinks
      • alcohol, sedatives and othe tranquilizers may increase drowsiness
      • use caution 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



  • each tablet contains:calcium 30 mg
  • each tablet contains:phosphorus 15 mg
  • store  at room temperature
  • protct from moisture
  • DO NOT USE IF  PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Questions?



call toll free 1-844-912-4012


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