drug facts

drug facts
SPL v5
SPL
SPL Set ID edfe32b5-9213-4350-9508-2530ee26c5d5
Route
oral
Published
Effective Date 2025-03-18
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 light mineral oil polyethylene glycol, unspecified water sorbitan sorbitol lecithin, soybean mannitol

Identifiers & Packaging

Pill Appearance
Imprint: PC5 Shape: oval Color: blue Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-08-01
Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 50 mg

Medication Information

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
Other Information
  • store between 15-30°C (59°-86°F)
Inactive Ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Description

Diphenhydramine HCl 50 mg

Principal Display Panel

Compare to the active ingredient in Unisom® SleepGels®*

Nighttime Sleep-Aid

50 mg Diphenhydramine HCl

SOFTGELS

ONE SOFTGEL PER DOSE

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

Distributed by

Target Corporation

Minneapolis, MN 55403



Use

for relief of occasional sleeplessness.

Do Not Use
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label
TARGET (up&up) Nighttime Sleep Aid
Questions Or Comments?

Call 1-800-910-6874

When Using This Product

avoid alcoholic drinks.

Stop Use and Ask A Doctor If

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

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 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

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
Other Information (Other information)
  • store between 15-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol, sorbitan, white ink

Principal Display Panel

Compare to the active ingredient in Unisom® SleepGels®*

Nighttime Sleep-Aid

50 mg Diphenhydramine HCl

SOFTGELS

ONE SOFTGEL PER DOSE

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.

Distributed by

Target Corporation

Minneapolis, MN 55403



Use

for relief of occasional sleeplessness.

Do Not Use (Do not use)
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Package Label
TARGET (up&up) Nighttime Sleep Aid
Questions Or Comments? (Questions or comments?)

Call 1-800-910-6874

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

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

Diphenhydramine HCl 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:44.760171 · Updated: 2026-03-14T23:08:01.024401