Diphenhydramine Hydrochloride
FDA Label NDC 54868-1050

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Diphenhydramine Hydrochloride (NDC 54868-1050). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, keep out of the reach of children., directions, inactive ingredients, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 20° to 25°C (68° to 77°F) [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

50 mg X 30 Capsules (Label)

50 mg X 30 Capsules (Label)

DiphenhydrAMINE

Hydrochloride

Capsules USP

50 mg

30 Capsules


* Please review the disclaimer below.