Indications and uses
for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Nighttime sleep aid
- Manufacturer
- ASCENT CONSUMER PRODUCTS, INC
- Effective date
- 2025-05-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:14
Label at a glance#
ProductNighttime sleep aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
take only one dose per day (24 hours)- see overdose warning adults & children 12 yrs & over 2 25mg softgels(50mg) at bedtime if needed or as directed by a doctor children under 12 yrs do not use store at 20-25 ° C (68-77 ° F) avoid excessive heat above 40 o C (104 o F) protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
Warnings
Do not use
for children under 12 years if 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
difficulty in urniation due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
taking sedative or tranquilizers
When usiing this product avoid alcoholic beverages
Keep out of reach of children
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
- difficulty in urination due to an 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
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.
Ask a doctor or pharmacist before use if you are
taking sedative or tranquilizers
Ask a doctor before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland
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
- take only one dose per day (24 hours)- see overdose warning
| 2 25mg softgels(50mg) at bedtime if needed or as directed by a doctor |
| do not use |
Other information
- store at 20-25 °C (68-77 °F)
- avoid excessive heat above 40 oC (104 oF)
- protect from light
Inactive ingredients
edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol
Questions or comments?
1-800-719-9260
Questions ?
1-888-547-5492
Other Information- Storage
Store at no greater than 25 degree C
avoid excessive heat above 40 degree C
protect from light
Package/Label Principal Display Panel
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 |
|---|---|---|---|---|---|---|
| 42829-925-20 | Nighttime sleep aid | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Nighttime sleep aid
- Diphenhydramine HCl
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SORBITOL
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42829-925 | 42829-925-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| 357e5f39-d08e-c95b-e063-6294a90a408d | 357e6165-6ffe-b05f-e063-6394a90a4ef6 | 2025-05-16 | Warnings | 357e5f39-d08e-c95b-e063-6294a90a408d 357e6165-6ffe-b05f-e063-6394a90a4ef6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.