Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID c2823bad-540f-4662-8dcc-58e9f0d94efb

Route

ORAL

Published

Effective Date 2018-11-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium D&c Red No. 27 Hypromelloses Lactose, Unspecified Form Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AZ048 Shape: capsule Color: pink Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-12-15

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg

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:

sneezing
runny nose

Warnings

Do not use

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

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 times in 24 hours

adults and children 12 years and over: 1 to 2 caplets

children 6 to under 12 years: 1 caplet

children under 6 years of age : do not use

Active Ingredient

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

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

Ask A Doctor If You Have

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

If Pregnant Or Breast Feeding

ask a health professional before use

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Diphenhydramine HCl 25mg

Ask A Doctor Or Pharmacist Before Use If You

are taking sedatives or tranquilizers

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:

sneezing
runny nose

Purpose

Antihistamine

Warnings

Do not use

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

Directions

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 times in 24 hours

adults and children 12 years and over: 1 to 2 caplets

children 6 to under 12 years: 1 caplet

children under 6 years of age : do not use

Active Ingredient (Active ingredient)

Diphenhydramine HCl 25 mg

Inactive Ingredients

croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

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

Ask A Doctor If You Have (Ask a doctor if you have)

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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use

Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Diphenhydramine HCl 25mg

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

are taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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: sneezing runny nose", "Purpose": "Antihistamine", "Warnings": "Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Directions": "take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over: 1 to 2 caplets children 6 to under 12 years: 1 caplet children under 6 years of age : do not use", "Active ingredient": "Diphenhydramine HCl 25 mg", "Inactive Ingredients": "croscarmellose sodium, D&C red #27 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide", "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", "Ask a doctor if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland", "If pregnant or breast-feeding": "ask a health professional before use", "Keep Out of Reach of Children": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. ", "Package/Label Principal Display Panel": "Diphenhydramine HCl 25mg", "Ask a doctor or pharmacist before use if you": "are taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:18.162892 · Updated: 2026-03-14T23:01:45.300207