Indications and uses
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
nighttime sleep-aid
- Manufacturer
- Bionpharma Inc. | Patheon Softgels Inc.
- Effective date
- 2023-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:05:40
Label at a glance#
Productnighttime sleep-aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. ■ swallow whole; do not crush, chew, or dissolve
Storage and handling
■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each capsule)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
■ for relief of occasional sleeplessness
■ reduces time to fall asleep if you have difficulty falling asleep
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
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use
if you are taking sedatives or tranquilizers.
When using this product
■ avoid alcoholic beverages
■ be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks, consult your doctor. 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 Centre right away.
Directions
■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
■ swallow whole; do not crush, chew, or dissolve
Other information
■ store at 20°C to 25°C (68°F to 77°F)
■ avoid high humidity and excessive heat above 40°C (104°F).
■ protect from light
Inactive ingredients
FD&C blue #1, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
Questions or comments?
call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
SPL UNCLASSIFIED SECTION
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
†This product is not manufactured or distributed by the owners of Unisom ®SleepGels ®.
Made in USA using domestic and imported materials.
Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
R0223 Lot No.: Exp. Date
L0000704
160's count Label
†Compare to the active ingredient in Unisom ®SleepGels ®
NDC 69452-322-79
a+health
maximum strength
nighttime
sleep-aid
diphenhydramine HCl capsules, 50 mg
• fall asleep fast
• sleep soundly
• safe, non-habit forming
160 softgels**
**liquid-filled capsules
one softgel per dose
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69452-322-79 | nighttime sleep-aid | 160 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 160 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- nighttime sleep-aid
- Diphenhydramine HCl
- GLYCERIN
- GELATIN
- LECITHIN, SOYBEAN
- WATER
- SORBITAN
- MEDIUM-CHAIN TRIGLYCERIDES
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- FD&C BLUE NO. 1
- HYPROMELLOSE, UNSPECIFIED
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69452-322 | 69452-322-79 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| nighttime sleep-aid | DIPHENHYDRAMINE HCL | Bionpharma Inc. | c0074c77-287e-6c26-e053-2995a90a4d31 | 2023-12-26 | Warnings | 69452-322-79 69452-322 69452032279 0d63c644-46c2-b4c0-e063-6394a90a9dd3 c0074c77-287e-6c26-e053-2995a90a4d31 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.