Indications and uses
for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Sleep Aid
- Manufacturer
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
- Effective date
- 2025-11-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:18:19
Label at a glance#
ProductSleep Aid Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed 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
Storage and handling
each caplet contains: calcium 30 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from moisture store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Diphenhydramine HCl 25 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- 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.
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
- 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 30 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- protect from moisture
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Questions or comments?
1-800-426-9391
Principal display panel
CVS™
NDC 51316-367-12
SLEEP-AID
Diphenhydramine HCl, 25 mg, Nighttime Sleep-Aid
Helps to reduce difficulty in falling asleep Non-Habit forming
Compare to simply sleep® active ingredient*
100
MINI-CAPLETS
actual size
Does not
contain pain
reliever.
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
*This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Simply Sleep®.
50844 ORG101936712
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 |
|---|---|---|---|---|---|---|
| 51316-367-12 | Sleep AidNighttime | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 4 | |
| 51316-367-12 | Sleep AidNighttime | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 |
Products#
Every source-derived product name is available through these pages.
- Sleep Aid Nighttime
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- STARCH, CORN
- DIBASIC CALCIUM PHOSPHATE DIHYDRATE
- FD&C BLUE NO. 1 ALUMINUM LAKE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- SILICON DIOXIDE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51316-367 | 51316-367-12 |
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 Nighttime | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fe58ce40-ae88-4dc5-9486-e67041f6d852 | 2025-11-26 | Warnings | 51316-367-12 51316-367 51316036712 c98e1f9f-5f74-443d-a11b-1d2b2da9dd75 fe58ce40-ae88-4dc5-9486-e67041f6d852 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.