Dosage and administration
• adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
nighttime sleep aid
- Manufacturer
- Meijer Distribution Inc
- Effective date
- 2024-11-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:50:10
Label at a glance#
Productnighttime sleep aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Storage and handling
• store at 20-25°C (68-77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
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 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 over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor
Other information
- store at 20-25°C (68-77°F)
Inactive ingredients
edible ink*, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient
Questions or comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to Unisom® SleepGels® active ingredient
nighttime sleep-aid
Diphenhydramine HCl Softgels, 50 mg
Non-Habit Forming
60 Softgels
one softgel per dose
actual size
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- nighttime sleep aid
- diphenhydramine hcl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41250-696 | 41250-696-64, 41250-696-80, 41250-696-33 |
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, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| d012785d-28de-4d9b-804e-e3ff90346206 | 48a4184b-5c06-4cf7-9334-628f2ec56d52 | 2024-11-06 | Warnings | d012785d-28de-4d9b-804e-e3ff90346206 48a4184b-5c06-4cf7-9334-628f2ec56d52 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.