Indications and uses
relief of occasional sleeplessness
NIGHTTIME SLEEP AID-Diphenhydramine HCl 25 mg
- Manufacturer
- Health Pharma USA LLC
- Effective date
- 2026-07-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:43:47
Label at a glance#
ProductNighttime Sleep Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years of age and over: - take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses:
- 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
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
ask a doctor before use if you have
- a breathing problem such as asthma, emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
heart disease
ask your doctor or pharmacist before use if you are
- taking sedative or tranquilizers or any other sleep-aid
When using this product
- drowsiness will occur
- avoid alcoholic beverages and other drugs that cause drowsiness
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- 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. Insomnia may be a symptom of a serious underlying medical illness.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over:- take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years of age:do not use
Other Information
- Each caplet contains: Calcium 23.52 mg
- store at controlled room temperature 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
- read all product information before using
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Polyvinyl Alcohol, Talc, Titanium dioxide, Polyethylene Glycol, Lecithin, Brilliant Blue (FD&C Blue No. 1), Indico Carmel (FD&C Blue No. 2), Purified Water.
Questions or comments?
Call toll free 1-844-832-1138 9AM – 5PM Monday - Friday
Principal Display Panel-300 count
Principal Display Panel-600 count
Principal Display Panel-1000 count
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0371679110032 | GTIN-13: 0371679110032 EAN-13: 0371679110032 GTIN-12: 371679110032 UPC-A: 371679110032 GTIN storage (14 digits): 00371679110032 | label-300.jpg |
| Barcode | EAN-13 | 0371679110100 | GTIN-13: 0371679110100 EAN-13: 0371679110100 GTIN-12: 371679110100 UPC-A: 371679110100 GTIN storage (14 digits): 00371679110100 | label-1000.jpg |
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 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Sleep Aid
- Diphenhydramine HCl 25 mg
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- MICROCRYSTALLINE CELLULOSE
- CROSCARMELLOSE SODIUM
- WATER
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- FD&C BLUE NO. 1
- FD&C BLUE NO. 2
- TITANIUM DIOXIDE
- TALC
- LECITHIN, SOYBEAN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 71679-110 | 71679-110-03, 71679-110-06, 71679-110-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 11 | 2025-06-18 | full-release | 2026-06-01 01:03:27 |
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 25 MG | Health Pharma USA LLC | d659f747-9790-8bd6-e053-2995a90ae793 | 2026-07-07 | Warnings | 71679-110-10 71679-110-06 71679-110-03 71679-110 71679011010 71679011003 71679011006 55fecf57-0d0f-617b-e063-6394a90a17de d659f747-9790-8bd6-e053-2995a90ae793 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.