Label: CVS NIGHTTIME SLEEP AID- diphenhydramine hydrochloride and acetaminophen liquid

  • 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 September 12, 2023

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  • 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

    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

    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
    ▪
    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:

    CVS Nighttime Sleep Aid Berry Flavor
  • INGREDIENTS AND APPEARANCE
    CVS NIGHTTIME  SLEEP AID
    diphenhydramine hydrochloride and acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-448
    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:69842-448-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/12/2021
    Labeler - CVS PHARMACY (062312574)
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