Diphenhydramine Hcl 50mg, Usp

Diphenhydramine Hcl 50mg, Usp
SPL v2
SPL
SPL Set ID 114b71f9-36b1-4372-805e-65cbb61f2925
Route
ORAL
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (50 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 1000 Sorbitol Polyvinyl Acetate Phthalate Propylene Glycol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 206 Shape: oval Color: blue Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-03-31
Description

(in each softgel) Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep aid

Medication Information

Purpose

Nighttime sleep aid

Description

(in each softgel) Diphenhydramine HCl 50 mg

Uses
  • For relief of occasional sleeplessness.
Warnings

Do not use

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

    Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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

    When using this product

  • avoid alcoholic drinks

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

Directions
  • adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
  • children under 12 years: do not use
Active Ingredient

(in each softgel)

Diphenhydramine HCl 50 mg

Other Information
  • save carton for full directions and warnings
Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions Or Comments

Call 1-855-314-1850

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)

Package Label.principal Display Panel

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC:58805-006-00  Softgel Liquid filled

Structured Label Content

Uses
  • For relief of occasional sleeplessness.
Purpose

Nighttime sleep aid

Warnings

Do not use

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

    Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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

    When using this product

  • avoid alcoholic drinks

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

Directions
  • adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.
  • children under 12 years: do not use
Active Ingredient

(in each softgel)

Diphenhydramine HCl 50 mg

Other Information
  • save carton for full directions and warnings
Inactive Ingredients

Blue 1, gelatin, glycerin, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, sorbitol, titanium dioxide and water.

Questions Or Comments (Questions or Comments)

Call 1-855-314-1850

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)

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

DIPHENHYDRAMINE HYDROCHLORIDE SOFTGEL CAPSULE, USP 50 MG

NDC:58805-006-00  Softgel Liquid filled

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:55.436147 · Updated: 2026-03-14T22:53:57.959732