diphenhydramine hydrochloride capsules usp 50 mg

SPL v3

SPL

SPL Set ID 32033991-a4f0-f767-e063-6394a90a0b06

Route

oral

Published

Effective Date 2026-01-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

diphenhydramine (50 mg)

Inactive Ingredients

polyethylene glycol 600 water propylene glycol polyethylene glycol 400 sorbitol gelatin glycerin

Identifiers & Packaging

Pill Appearance

Shape: oval Color: white Size: 13 mm Score: 1

Marketing Status

otc monograph drug active Since 2025-04-08

Purpose

Nighttime sleep-aid

Description

Diphenhydramine Hydrochloride 50 mg

Medication Information

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Uses

for relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Description

Diphenhydramine Hydrochloride 50 mg

Section 51945-4

When Using This Product

avoid alcoholic drinks

Stop Use and Ask A Doctor If

sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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.

Active Ingredient (in Each Softgel)

Diphenhydramine Hydrochloride 50 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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Warnings

Do not use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Uses

for relief of occasional sleeplessness

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution

Section 51945-4 (51945-4)

When Using This Product (When using this product)

avoid alcoholic drinks

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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.

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

Diphenhydramine Hydrochloride 50 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

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

taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional sleeplessness", "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", "Directions": "adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor", "Inactive ingredients": "gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution", "When using this product": "avoid alcoholic drinks", "Stop use and ask a doctor if": "sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.", "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.", "Active ingredient (in each softgel)": "Diphenhydramine Hydrochloride 50 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", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:22.123348 · Updated: 2026-03-14T23:12:35.594126