diphenhydramine hydrochloride capsules usp 50 mg (dye-free)

diphenhydramine hydrochloride capsules usp 50 mg (dye-free)
SPL v2
SPL
SPL Set ID 3b1ea33b-8460-31cf-e063-6394a90a5534
Route
oral
Published
Effective Date 2025-07-30
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
Imprint: 02 Shape: oval Color: white Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-07-30
Purpose

Nighttime sleep-aid

Description

(in each softgel) Diphenhydramine Hydrochloride USP 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

(in each softgel) Diphenhydramine Hydrochloride USP 50 mg

Active Ingredient

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Bulk Package Label

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.

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.

Active Ingredient (Active ingredient)

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Bulk Package Label

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.

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:59.681386 · Updated: 2026-03-14T23:12:06.957806