Label: CVS NIGHTTIME SLEEP AID- diphenhydramine hydrochloride and acetaminophen liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 69842-496-12 - Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 14, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each 30 mL)
- Purpose
- Uses
-
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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
PRINCIPAL DISPLAY PANEL - 354 ml bottle
Compare to the active ingredient in ZzzQuil™ Night Pain Sleep-Aid*
NDC# 69842-496-12
Nighttime Sleep-AidPain Reliever
Diphenhydramine HClAcetaminophen
- •
- 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:
-
INGREDIENTS AND APPEARANCE
CVS NIGHTTIME SLEEP AID
diphenhydramine hydrochloride and acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-496 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 30 mL Inactive Ingredients Ingredient Name Strength 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 Color RED Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-496-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/24/2020 Labeler - CVS PHARMACY (062312574)