Sleep Aid
- Dosage form
- CAPSULE
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)
- Label updated
- 2025-04-03
- 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 between 15-30°C (59°-86°F)
Inactive ingredients
FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitan, sorbitol, white ink
Questions or comments?
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the Active Ingredient in Unisom® SleepGels®
Sleep-Aid Maximum Strength
Nighttime Sleep-Aid
Diphenhydramine HCL 50 mg
Help To Reduce Difficulty Falling Asleep
Softgels
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 CDMA, Inc
Novi, MI 48375
Package Label
[Image in the official label — see DailyMed source]
DailyMed Set ID: 25f32a1c-0687-45e9-8142-96cf63599090 · Version 3
NDC: 83324-151