Nighttime Sleep AidMaximum Strength
- Dosage form
- CAPSULE
- Labeler
- Care One (Retail Business Services, LLC.)
- Label updated
- 2025-05-23
- 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, sorbitol, sorbitan, white ink
Principal Display Panel
Compare to the Active Ingredient in Unisom® SleepGels®†
Maximum Strength
NIGHTTIME SLEEP - AID
Diphenhydramine HCI 50 mg
Helps to Reduce Difficulty Falling Asleep
SOFTGELS**
**Liquid Filled Capsules
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: ADUSA DISTRIBUTION, LLC
SALISBURY, NC 28147
For product questions or concerns,
contact us at 1-833-992-3872
Quality guaranteed or your money back.
Package Label
[Image in the official label — see DailyMed source]
DailyMed Set ID: 536cd7d6-a470-4614-89c8-6c3ada582a90 · Version 5
NDC: 72476-916