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Sleep Aid

Dosage form
CAPSULE
Labeler
FSA Store Inc. (Caring Mills)
Label updated
2025-03-28
Retrieved
2026-09-07
Active ingredients
DIPHENHYDRAMINE HYDROCHLORIDE
View original label and images on DailyMed ↗
Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

For relief of occasional sleeplessness.

Warnings

Do not use

  • for 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

  • 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.

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.

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 15-30ºC (59-86ºF)
Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

*Compare to the active ingredient in Unisom® SleepGels®

Sleep Aid

Diphenhydramine HCl 50 mg

Nighttime sleep aid

  • Fall asleep fast
  • Sleep soundly
  • Wake up refreshed

Softgels

One Softgel per dose

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for FSA Store Inc.

5473 BLAIR ROAD

SUITE 100

PMB 24308

DALLAS, TX 75231

Product Label

[Image in the official label — see DailyMed source]

DailyMed Set ID: 9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9 · Version 5
NDC: 81522-916