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
good sense sleep aid
- Manufacturer
- L. Perrigo Company
- Effective date
- 2024-11-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:50:13
Label at a glance#
Productgood sense 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
Principal Display Panel
Non-Habit Forming
One Softgel Per Dose
Sleep Aid Softgels
Diphenhydramine HCl Softgels, 50 mg
Nighttime Sleep-Aid
Actual Size
Compare to active ingredient of Unisom® SleepGels®
100% SATISFACTION GUARANTEED
32 Softgels
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-1909-64 | EA - Each | 0113-1909 | dd386146-4f0e-45d5-92bb-6a1ff8064d72 | 1 | 2022-04-06 |
Products#
Every source-derived product name is available through these pages.
- good sense sleep aid
- diphenhydramine hydrochloride
- DIPHENHYDRAMINE
- FD&C BLUE NO. 1
- GLYCERIN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0113-1909 | 0113-1909-64 |
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 |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| 5f2939d6-affa-4b50-bb37-f8c723c515aa | 97d65237-0aa3-4a53-9b0b-d5fb5533f69b | 2024-11-06 | Warnings | 5f2939d6-affa-4b50-bb37-f8c723c515aa 97d65237-0aa3-4a53-9b0b-d5fb5533f69b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.