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diphenhydramine hydrochloride

Dosage form
CAPSULE
Labeler
RedPharm Drug, Inc.
Label updated
2020-01-20
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
PURPOSE

Antihistamine

USES

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


runny nose and sneezing

itching of the nose or throat

itchy, watery eyes.

WARNINGS

Ask a doctor before use if you have


a breathing problem such as emphysema or chronic bronchitis

glaucoma

difficulty in urination due to enlargement of the prostate gland

Do not use with any other product containing diphenhydramine, including products used topically.

Ask a doctor or pharmacist before use if you are


taking tranquilizers or sedatives

taking other products containing diphenhydramine

When using this product


Do not exceed recommended dosage

excitability may occur, especially in children

marked drowsiness may occur

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

use caution when driving a motor vehicle or operating machinery

If pregnant or breastfeeding ask a health professional before use.

KEEP OUT OF THE REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DIRECTIONS


Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.

Children 12 years and under: Consult a Doctor

STORAGE AND HANDLING

Keep tightly closed. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Manufactured for Sandoz Inc.

Princeton, NJ 08540

Manufactured by Epic Pharma, LLC

Laurelton, NY 11413

L1812

Rev. 11/08

INACTIVE INGREDIENTS

Colloidal Silicon Dioxide, Corn Starch, D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Anhydrous Lactose, Magnesium Stearate, Silicon Dioxide and Sodium Lauryl Sulfate.

DOSAGE & ADMINISTRATION

Adults and Children 12 years and over: 25 to 50 mg (1 to 2 capsules) every 4 to 6 hours, not to exceed 12 capsules in 24 hours.

Children 12 years and under: Consult a Doctor

PURPOSE

Antihistamine

KEEP OUT OF THE REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center right away.

ACTIVE INGREDIENT SECTION

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

DailyMed Set ID: 42b31ac0-9de1-5763-e054-00144ff8d46c · Version 3
NDC: 67296-0876