Nighttime Sleep Aid
- Dosage form
- CAPSULE
- Labeler
- WR Group, Inc.
- Label updated
- 2025-03-28
- 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®
NIGHTTIME
Sleep Aid
Diphenhydramine HCI 50 mg
FALL ASLEEP FAST | SLEEP SOUNDLY
WAKE UP REFRESHED
SOFTGELS**
ONE SOFTGEL PER DOSE
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
†This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Unisom® SleepGels®.
Distributed by:
Kolbe & Schmitt®
2625 S. 16th St,
Suite 150, Phoenix, AZ 85034
Package Label
[Image in the official label — see DailyMed source]
DailyMed Set ID: d28d0f6d-8029-4e31-b417-4f8f864d840e · Version 7
NDC: 69607-0916