Diphenhydramine Hydrochloride Capsules, Usp 25 Mg Dye Free

SPL v2

SPL

SPL Set ID 36ba3ff2-1965-aa56-e063-6294a90afe17

Route

ORAL

Published

Effective Date 2025-06-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Polyethylene Glycol 400 Gelatin Glycerin Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: 04 Shape: capsule Color: white Size: 15 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Diphenhydramine HCl 25mg

Purpose

Antihistamine

Medication Information

Warnings and Precautions

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

Purpose

Antihistamine

Description

Diphenhydramine HCl 25mg

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 51945-4

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and over	1 to 2 capsules
children 6 to under 12 years of age	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, propylene glycol, purified water, sorbitol sorbitan solution.

Questions Or Comments?

1-888-333-9792

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

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 right away. (1-800-222-1222)

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Active Ingredient (in Each Liquid Filled Capsules)

Diphenhydramine HCl 25mg

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

Warnings and Precautions (34071-1)

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

Section 51945-4 (51945-4)

Purpose

Antihistamine

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours

adults and children 12 years of age and over	1 to 2 capsules
children 6 to under 12 years of age	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, propylene glycol, purified water, sorbitol sorbitan solution.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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

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

ask a health professional before use

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)

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

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

taking sedatives or tranquilizers

Active Ingredient (in Each Liquid Filled Capsules) (Active Ingredient (in each liquid-filled capsules))

Diphenhydramine HCl 25mg

Advanced Ingredient Data

[{"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "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: runny nose sneezing", "34071-1": "to make a child sleepy with any other product containing diphenhydramine, even one used on skin", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 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, propylene glycol, purified water, sorbitol sorbitan solution.", "Questions or comments?": "1-888-333-9792", "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", "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 right away. (1-800-222-1222)", "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", "Ask a Doctor or Pharmacist before use if you are": "taking sedatives or tranquilizers", "Active Ingredient (in each liquid-filled capsules)": "Diphenhydramine HCl 25mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:59.671144 · Updated: 2026-03-14T23:12:06.957806