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Diphenhydramine Hydrochloride

Dosage form
CAPSULE
Labeler
NuCare Pharmaceuticals,Inc.
Label updated
2022-12-22
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
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 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

Distributed by

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233,

Livonia, MI 48152

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

DailyMed Set ID: ef2c4ec3-a5c1-cc08-e053-2a95a90ade3b · Version 2
NDC: 68071-2895