Indications and uses
reduces time to fall asleep if you have difficulty falling asleep for relief of occasional sleeplessness
Sleep-Aid Chewables
- Manufacturer
- CVS PHARMACY | LNK International, Inc.
- Effective date
- 2025-05-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 01:00:47
Label at a glance#
ProductSleep-Aid Chewables Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not take more than directed chew or crush tablets completely before swallowing; do not swallow tablets whole take only one dose per day (24 hours) adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor children under 12 years: do not use
Storage and handling
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each chewable tablet)
Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
- reduces time to fall asleep if you have difficulty falling asleep
- for 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
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
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- take only one dose per day (24 hours)
- adults and children 12 years and over: 2 chewable tablets at bedtime if needed, or as directed by a doctor
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients
D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose
Questions or comments?
1-800-426-9391
Principal display panel
CVSHealth®
Nighttime
Sleep-Aid
Chewables
DIPHENHYDRAMINE HCl, 25 mg
CHEWABLE TABLETS
Nighttime sleep-aid
Non-habit forming tablets
• For a restful night's sleep
• Not for treating pain, cold or flu
Grape Flavor
18 CHEWABLE TABLETS
Chew or crush tablets completely before swallowing.
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0119B68544
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
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guaranteed
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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 |
| cb89b86a-369e-4204-8910-ae797c503af3 | Product name | 1 | 20230706 |
| d4880ace-a516-8c47-8dfd-73a4ba5887d7 | Product name | 2 | 20180830 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 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 |
|---|---|---|---|---|---|---|
| 69842-958-44 | Sleep-Aid ChewablesNighttime | 6 in 1 BLISTER PACK | TABLET, CHEWABLE | 6 | 9 | |
| 69842-958-44 | Sleep-Aid ChewablesNighttime | 3 in 1 CARTON | TABLET, CHEWABLE | 3 | 9 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sleep-Aid Chewables Nighttime
- Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- D&C RED NO. 27 ALUMINUM LAKE
- D&C RED NO. 30
- DEXTROSE MONOHYDRATE
- ETHYLCELLULOSE, UNSPECIFIED
- FD&C BLUE NO. 1 ALUMINUM LAKE
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MANNITOL
- STEARIC ACID
- SUCRALOSE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-958 | 69842-958-44 |
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 |
|---|---|---|---|---|---|---|
| 54e91d5b-e464-4cb1-8da1-f6ae82ac025c | d6579eed-6a53-4287-bf3e-431121dc0f83 | 2025-05-10 | Warnings | 54e91d5b-e464-4cb1-8da1-f6ae82ac025c d6579eed-6a53-4287-bf3e-431121dc0f83 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.