Label: CVS NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • Active ingredients (in each 30 mL)

    Acetaminophen 650 mg

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 12.5 mg

  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms:

    ▪
    cough due to minor throat and bronchial irritation
    ▪
    sore throat
    ▪
    headache
    ▪
    minor aches and pains
    ▪
    fever
    ▪
    runny nose and sneezing
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 4 doses in 24 hours, which is the maximum daily amount for this product
    •
    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.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    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.
    ▪
    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    ▪
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    ▪
    liver disease
    ▪
    glaucoma
    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    a breathing problem such as emphysema or chronic bronchitis
    ▪
    trouble urinating due to an enlarged prostate gland
    ▪
    persistent or chronic cough as occurs with smoking, asthma, or emphysema
    ▪
    a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    ▪
    taking sedatives or tranquilizers
    ▪
    taking the blood thinning drug warfarin

    When using this product

    ▪
    excitability may occur, especially in children
    ▪
    marked drowsiness may occur
    ▪
    avoid alcoholic drinks
    ▪
    be careful when driving a motor vehicle or operating machinery
    ▪
    alcohol, sedatives, and tranquilizers may increase drowsiness

    Stop use and ask a doctor if

     
    ▪
    pain or cough gets worse or lasts more than 7 days
    ▪
    fever gets worse or lasts more than 3 days
    ▪
    redness or swelling is present
    ▪
    new symptoms occur
    ▪
    cough comes back or occurs with rash or headache that lasts. 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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 as directed
    •
    only use the dose cup provided
    •
    do not exceed 4 doses per 24 hrs

    adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use
  • Other information

    •
    each 30 mL contains: sodium 16 mg
    •
    store at room temperature and do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, D&C Yellow No. 10, disodium edetate, FD&C Green No. 3, FD & C Yellow No 6, flavors, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose.

    Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    Compare to the active ingredients in VICKS® Nyquil™Cold & Flu*

    NDC 51316-692-12

    Nighttime Cold & Flue Relief

    Acetaminophen, Dextromethorphan succinate,

    Doxylamine HBr

    Headache, Fever, Sore Throat

    Minor Aches & Pains

    Sneezing, Runny Nose, Cough

    Original Flavor

    12 FL OZ (354 mL)

    Distributed by:

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Nyquil™Cold & Flu*

    CVS Nighttime Cold and Flu Relief
  • INGREDIENTS AND APPEARANCE
    CVS NIGHTTIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-692
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-692-12354 mL in 1 BOTTLE; Type 0: Not a Combination Product02/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01002/13/2023
    Labeler - CVS PHARMACY (062312574)
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