Sleep Aid
- Dosage form
- CAPSULE
- Labeler
- Strategic Sourcing Services LLC
- Label updated
- 2025-03-21
- Retrieved
- 2026-09-07
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE
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 at 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
Principal Display Panel
COMPARE TO UNISOM® SLEEPGELS® ACTIVE INGREDIENT†
MAXIMUM STRENGTH
Sleep-Aid
Diphenhydramine HCl 50 mg
NIGHTTIME SLEEP-AID
For relief of occasional sleeplessness
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: Mckesson Corp.,
via Strategic Sourcing Services LLC.
Memphis TN 38141
www.fosterandthrive.com
Package Label
[Image in the official label — see DailyMed source]
DailyMed Set ID: a512413c-639b-4846-b016-332a78b50ab7 · Version 3
NDC: 70677-1151