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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
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Remedyrepack 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

    • 50 MG

    • to make a child sleepy
    • with any other product containing diphenhydramine, including one applied topically

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

    • 50 MG

    • 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 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 over1 to 2 capsules
    children 6 years to under 12 years of age1 capsule
    children under 6 years of agedo not use this product in children under 6 years of age

    50 MG

    adults and children 12 years of age and over1 capsule
    children 6 years to under 12 years of ageAsk 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


Distributed By



MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233,
Livonia, MI 48152


Package Label.Principal Display Panel



DRUG: Diphenhydramine Hydrochloride

GENERIC: Diphenhydramine Hydrochloride

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-0861-0

COLOR: pink

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: cpc;836

PACKAGING: 30 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 1

    • INACTIVE INGREDIENT(S):

* Please review the disclaimer below.