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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 TEASPOON (5 ML))
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    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 Physicians Total Care, 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 Teaspoon (5 Ml))



Diphenhydramine HCl USP 12.5 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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

Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over2 to 4 teaspoons (25 mg to 50 mg)
    children 6 to under 12 yearsask a doctor
    children 4 to 5 yearsdo not use unless directed by a doctor
    children under 4 yearsdo not use

Other Information



  • each teaspoon (5 mL) contains: sodium 5 mg
  • store between 20°-25°C (68°-77°F). Protect from light.

Inactive Ingredients



artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution


Questions?



call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time


Principal Display Panel




NDC 54868-1227-0

image of package label - 1227

image of package label - 1227

TAMPER-EVIDENT


Diphenhydramine HCl USP
12.5 mg per 5 mL)

ONE PINT (473 mL)

ANTIHISTAMINE

ALCOHOL-FREE
SUGAR-FREE
CHERRY-FLAVORED

TAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.

NOT FOR HOUSEHOLDS
WITH YOUNG CHILDREN



* Please review the disclaimer below.