Diphenhydramine Hydrochloride Capsules, Usp 25 Mg (dye And Propylene Glycol Free)

SPL v2

SPL

SPL Set ID 335b6ddd-fdc8-1120-e063-6394a90add41

Route

ORAL

Published

Effective Date 2026-01-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Gelatin Glycerin Polyethylene Glycol 400 Sorbitol Water

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: white Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Diphenhydramine Hydrochloride USP 25mg

Purpose

Antihistamine

Medication Information

Indications and Usage

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

Purpose

Antihistamine

Description

Diphenhydramine Hydrochloride USP 25mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50568-5

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

Section 51945-4

Section 53414-9

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

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
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° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

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 Softgel)

Diphenhydramine Hydrochloride USP 25mg

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

Structured Label Content

Indications and Usage (34067-9)

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 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.

Section 50568-5 (50568-5)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

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
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° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.

Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution

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 Softgel) (Active ingredient (in each softgel))

Diphenhydramine Hydrochloride USP 25mg

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

Advanced Ingredient Data

[{"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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 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° to 25°C (68° to 77°F). Avoid high humidity and excessive heat. Protect from light.", "Inactive Ingredients": "gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol sorbitan solution", "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 softgel)": "Diphenhydramine Hydrochloride USP 25mg", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:22.129629 · Updated: 2026-03-14T23:12:35.594126