Indications and uses
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
■ 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
■ 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
Diphenhydramine HCl 50 mg
Nighttime sleep-aid
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
Do not use
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin.
■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland
if you are taking sedatives or tranquilizers.
■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery
sleeplessness persists continuosly for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
■
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
■ 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
FD&C blue #1, gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution
call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
Distributed By
AmerisourceBergen
1 West First Ave
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com
ABC#: 10287782 Rev: 04/24
†This product is not manufactured or distributed by the owners of Unisom® SleepGels®.
Mfg. Lic. No.: TN00002123
Made in India
L0000887
R0724
Lot No.:
Exp. Date:
Compare to the active ingredient in Unisom® SleepGels®
NDC 46122-775-64
GOOD
NEIGHBOR
PHARMACY
Maximum Strength
Nighttime Sleep-Aid
Diphenhydramine HCl Capsules, USP 50 mg
Fall Asleep Fast
• sleep soundly • safe, non-habit forming
One Softgel Per Dose
60 softgels** | (**Liquid-filled capsules)
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46122-775-64 | Nighttime Sleep-Aid | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 3 | |
| 46122-775-64 | Nighttime Sleep-Aid | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-775-64 | EA - Each | 46122-775 | 98379b72-6f5b-4996-8e59-0940c0101eef | 1 | 2025-08-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 46122-775 | 46122-775-64 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 | AMERISOURCE BERGEN | 16b2edd2-c16b-5713-e063-6394a90acf46 | 2025-12-01 | Warnings | 46122-775-64 46122-775 46122077564 44e8445b-c2fe-375a-e063-6294a90a5b91 16b2edd2-c16b-5713-e063-6394a90acf46 |
Adverse event summaries are temporarily unavailable. Other product information remains available.