Indications and uses
For relief of occasional sleeplessness.
Sleep Aid
- Manufacturer
- MEIJER, INC.
- Effective date
- 2022-09-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:52:58
Label at a glance#
ProductSleep Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
adults and children 12 years of age and older: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
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 right away (1-800-222-1222).
Directions
- adults and children 12 years of age and older: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other information
- store between 15-30ºC (59-86ºF)
Inactive ingredients
edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan*, sorbitol
*contains one or more of these ingredients
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the active ingredient in Unisom® SleepGels®*
MAXIMUM STRENGTH
Sleep Aid
Diphenhydramine HCl | 50 mg
Nighttime Sleep-Aid
Safe, non-habit forming
SOFTGELS
ONE SOFTGELS PER DOSE
†This product is not manufactured or distributed by Chattem, Inc., 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.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
Product Label
Products#
Every source-derived product name is available through these pages.
- Sleep Aid Nighttime
- Diphenhydramine Hydrochloride
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41250-659 | 41250-659-32, 41250-659-64 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 076cff6d-8734-45a9-b2a9-92bda3c34313 | 40419127-2798-4d90-be5d-3e686bd357fd | 2022-09-26 | Warnings | 076cff6d-8734-45a9-b2a9-92bda3c34313 40419127-2798-4d90-be5d-3e686bd357fd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.