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diphenhydramine hydrochloride

Dosage form
CAPSULE
Labeler
Physicians Total Care, Inc.
Label updated
2012-06-05
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredient (in each capsule)

Diphenhydramine Hydrochloride 25 mg

Diphenhydramine Hydrochloride 50 mg

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 ny 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
  • 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
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.

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



Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146

HOW SUPPLIED

DiphenhydrAMINE Hydrochloride Capsules USP

50 mg

Bottles of 30
NDC 54868-1050-1
Bottles of 100
NDC 54868-1050-5

Package Label - Principal Display Panel

NDC 54868-1050-1

[Image in the official label — see DailyMed source]

DiphenhydrAMINE

Hydrochloride

Capsules USP

50 mg

30 Capsules


DailyMed Set ID: 8975a041-76dd-4c5e-aa83-e1021d55a084 · Version 1
NDC: 54868-1050