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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 BANDED CAPSULE)
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST
    7. WHEN USING THIS PRODUCT
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. DISTRIBUTED BY

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals, Inc.. 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 Banded Capsule)



Diphenhydramine HCl… 25 mg

Diphenhydramine HCl… 50 mg


Purpose



Antihistamine


Use



25 MG

  • •Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • •runny nose
    • •sneezing
    • •itchy, watery eyes
    • •itchy throat and nose
    • •Temporarily relieves these symptoms due to the common cold:
      • •runny nose
      • •sneezing

        • 50 MG

        • •Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold
          • •sneezing
          • •runny nose
          • •itchy, watery eyes
          • •itchy throat and nose

Warnings



Do not use

25 MG

  • •to make a child sleepy
  • •with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



25 MG

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

Ask A Doctor Or Pharmacist



before use if you are taking sedatives or tranquilizers


When Using This Product



  • •marked drowsiness may occur
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •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 right away.


Directions



  • •Take every 4-6 hours
  • •Do not take more than 6 doses in 24 hours

    • 25 MG

    adults and children 12 years of age and over

    1 to 2 capsules

    children 6 years to under 12 years of age

    1 capsule

    children under 6 years of age

    do not use this product in children under 6 years of age

    50 MG

    adults and children 12 years of age and over

    1 capsule

    children 6 years to under 12 years of age

    Ask a doctor, the proper dosage strength is not available in this package**

    **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.


Other Information



  • •Store at 20°C – 25°C (68°F – 77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature]
  • •Protect from moisture
  • •Contains lactose

Inactive Ingredients



D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.


Questions?



Questions or comments? (800) 616-2471


* Please review the disclaimer below.