Benadryl
FDA Label NDC 76413-332

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Benadryl (NDC 76413-332). 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 other, active ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
    •   adults and children 12 years and over  1 to 2 capsules
      children 6 to under 12 years  1 capsule
      children under 6 years  do not use this product in children under 6 years of age

Other Information

  • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
  • do not use if carton is open or blister unit is broken

Inactive Ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.

Questions Or Comments?

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

Principal Display Panel - 25 Mg Capsule Blister Pack Carton Label

Austin/Travis Co. Health & Human Services Dept.

Benadryl
25mg/24
Caps

Date:

Name:
Dr.

USE AS DIRECTED.

1/1/01

123456

Benadryl 25mg/24 CAPS NDC 76413-332-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
Mckneil

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel (25 mg Capsule Blister Pack Carton Label)

Principal Display Panel (25 mg Capsule Blister Pack Carton Label)

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