Diphenhydramine Hcl 25 Mg

SPL v1

SPL

SPL Set ID 3e45d7ea-2a97-422a-b73a-c48bc2d1dea5

Route

ORAL

Published

Effective Date 2012-12-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Methylparaben Polyethylene Glycol 400 Propylparaben Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-01-01

Description

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Uses

for relief of occassional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products

Directions

Take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

Other Information

store at 20-25˚C (68-77˚F)
avoid excessive heat above 40˚C (104˚F) and high humidity
protect from light

Inactive Ingredients

FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Diphenhydramine Hydrochloride Capsules, USP 25 mg

Active Ingredient in Each Softgel

Diphenhydramine HCl 25 mg

Structured Label Content

Uses

for relief of occassional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products

Directions

Take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

Other Information

store at 20-25˚C (68-77˚F)
avoid excessive heat above 40˚C (104˚F) and high humidity
protect from light

Inactive Ingredients

FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Diphenhydramine Hydrochloride Capsules, USP 25 mg

Active Ingredient in Each Softgel (Active Ingredient in each Softgel)

Diphenhydramine HCl 25 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occassional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Warnings": "Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products", "Directions": "Take only one dose per day (24 hours) - see Overdose warning adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor", "Other Information": "store at 20-25˚C (68-77˚F) avoid excessive heat above 40˚C (104˚F) and high humidity protect from light", "Inactive Ingredients": "FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide", "Principal Display Panel": "Diphenhydramine Hydrochloride Capsules, USP 25 mg", "Active Ingredient in each Softgel": "Diphenhydramine HCl 25 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.272492 · Updated: 2026-03-14T22:53:21.930902