Indications and uses
▪ for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
CVS Nighttime Sleep-aid Pain Reliever
- Manufacturer
- CVS PHARMACY
- Effective date
- 2026-08-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- daily-update
- Hydrated at
- 2026-08-18 02:03:29
Label at a glance#
ProductCVS Nighttime Sleep Aid
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
▪ take only one dose (30 mL) per day (24 hours) ▪ Only use dose cup provided adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use
Storage and handling
▪ each 30 mL contains: sodium 10 mg ▪ store at room temperature ▪ very low sodium
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each 30 mL)
Acetaminophen 1000 mg
Diphenhydramine HCl 50 mg
Purpose
Pain reliever
Nighttime sleep-aid
Uses
- for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hrs., which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- avoid alcoholic beverages
- drowsiness will occur
- do not drive a motor vehicle or operate machinery
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
These could be signs of a serious condition.
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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only one dose (30 mL) per day (24 hours)
- Only use dose cup provided
adults & children 12 yrs & over | 30 mL at bedtime |
children under 12 yrs | do not use |
Other information
- each 30 mL contains: sodium 10 mg
- store at room temperature
- very low sodium
Inactive ingredients
citric acid, flavors, FD&C Blue No. 1, FD&C Red No. 40, glycerin, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.
Questions or comments?
1-866-467-2748
PRINCIPAL DISPLAY PANEL - 354 ml bottle
Compare to the active ingredient in Vicks® ZzzQuil™ Night Pain Sleep-Aid*
NDC# 69842-448-12
Nighttime Sleep-Aid
Pain Reliever
Diphenhydramine HCl
Acetaminophen
- Fall Asleep Fast
- Max Strength Pain Reliever
- Non-Habit Forming
Berry Flavor
Naturally and Artificially Flavored
No Added Alcohol
12 FL. OZ. (354 ml)
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® ZzzQuil™ Nigh Pain Sleep-Aid.
Distributed by:
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- CVS Nighttime Sleep Aid
- Diphenhydramine Hydrochloride and Acetaminophen
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- CITRIC ACID MONOHYDRATE
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- POTASSIUM CITRATE
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69842-448 | 69842-448-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POTASSIUM CITRATE | EE90ONI6FF | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-12-08 | full-release | 2026-06-01 01:20:35 |
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 |
|---|---|---|---|---|---|---|
| CVS Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN | CVS PHARMACY | 333e170e-52cd-4218-8d15-0bf3c5c75cb9 | 2026-08-14 | Warnings | 69842-448-12 69842-448 69842044812 335bccb9-9abe-4e6f-b081-ff5cc3b464ba 333e170e-52cd-4218-8d15-0bf3c5c75cb9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.