Dosage and administration
adults and children 12 years and over take 2 caplets at bedtime if needed, or as directed by a doctor children under 12 years do not use
Sleep Aid
- Manufacturer
- Velocity Pharma LLC
- Effective date
- 2018-05-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:55:32
Label at a glance#
ProductSleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Storage and handling
each caplet contains: calcium 15 mg store between 20-25 ° C (68-77 ° F). Avoid high humidity. Protect from light. do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep aid
Use
for relief of occasional sleeplessness
Warnings
Do not use
- in 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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- avoid alcoholic drinks
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
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 and over | take 2 caplets at bedtime if needed, or as directed by a doctor |
| children under 12 years | do not use |
Other information
- each caplet contains: calcium 15 mg
- store between 20-25 °C (68-77 °F). Avoid high humidity. Protect from light.
- do not use if carton tape imprinted with "SAFETY SEAL®" is broken or missing or blister unit is torn or broken
Inactive ingredients
carnauba wax, croscarmellose sodium, dibasic calcium phosphate, FD&C Blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Questions or comments?
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
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 |
|---|---|---|---|---|---|---|
| 76168-015-07 | Sleep Aid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 76168-015-07 | Sleep Aid | 36 in 1 BOTTLE | TABLET, FILM COATED | 36 | 3 | |
| 76168-015-12 | Sleep Aid | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 3 | |
| 76168-015-12 | Sleep Aid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sleep Aid
- diphenhydramine hydrochloride
- CARNAUBA WAX
- CROSCARMELLOSE SODIUM
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C BLUE NO. 1
- ALUMINUM OXIDE
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYSORBATE 80
- TITANIUM DIOXIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76168-015 | 76168-015-07, 76168-015-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Velocity Pharma LLC | 035454a1-d23b-4faf-8fac-a59fc77ce18c | 2018-05-14 | Warnings | 76168-015-07 76168-015-12 76168-015 76168001512 76168001507 6c311047-4bf2-44ad-e053-2a91aa0ad047 035454a1-d23b-4faf-8fac-a59fc77ce18c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.