CVS NIGHTTIME SLEEP AID- diphenhydramine hydrochloride and acetaminophen liquid 
CVS PHARMACY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Nighttime Sleep-aid Pain Reliever

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

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.

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
very low sodium

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

avoid alcoholic beverages
drowsiness will occur
do not drive a motor vehicle or operate machinery

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.

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 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

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 ZzzQuil™ Night Pain Sleep-Aid*

NDC# 69842-496-12


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 ZzzQuil™ Nigh Pain Sleep-Aid.

Distributed by:

CVS Nighttime Sleep Aid Berry Flavor
CVS NIGHTTIME  SLEEP AID
diphenhydramine hydrochloride and acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-496
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-496-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/24/2020
Labeler - CVS PHARMACY (062312574)

Revised: 12/2020
Document Id: a8521e9c-4ca5-4a18-a87b-0d5a23cf5c48
Set id: a8521e9c-4ca5-4a18-a87b-0d5a23cf5c48
Version: 1
Effective Time: 20201214
 
CVS PHARMACY