Benadryl®

Benadryl®
SPL v1
SPL
SPL Set ID 0bbc8617-3833-4a97-9749-7c0e793fc9c5
Route
ORAL
Published
Effective Date 2017-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: BENADRYL Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-03-01
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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)

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9

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

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
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
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)

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
Active Ingredient (in Each Capsule)

Diphenhydramine HCl 25 mg

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
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.

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

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
Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (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
Principal Display Panel 25 Mg Capsule Blister Pack Carton Label (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.260987 · Updated: 2026-03-14T22:54:50.171645