Label: KROGER NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 30 mL dose cup)Purpose

    Acetaminophen 650 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 30 mg

    Cough suppressant

    Doxylamine succinate 12.5 mg

    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

    Sore throat warning

    If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
    ▪
    to make a child sleep

    Ask a doctor before use if you have

    ▪
    liver disease
    ▪
    glaucoma
    ▪
    cough that occurs with too much phlegm (mucus)
    ▪
    a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
    ▪
    trouble urinating due to enlarged prostate gland
    ▪
    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.

    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.

    Overdose warning

    Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 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, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose, xanthan gum

  • Questions?

    1-800-467-2748

  • Principal Display Panel - 236 ml Bottle Label

    Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu Nighttime Relief*

    NDC# 30142-629-12

    Nighttime Cold & Flu Relief

    Acetaminophen, Doxylamine,

    Dextromethorphan HBr

    •
    Headaches, Fever & Sore Throat
    •
    Minor Aches & Pains
    •
    Sneezing, Runny Nose
    •
    Cough

    Natural Cherry Flavor

    12 FL. OZ. (354 mL)

    Distributed by:

    *This product is not manufacturing or distributed by Procter & Gamble, the distributor of Vicks® NyQuil™ Cold & Flu Nighttime Relief.

    Kroger Nighttime Cold & Flu Relief
  • INGREDIENTS AND APPEARANCE
    KROGER  NIGHTTIME COLD AND FLU RELIEF
    acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-629
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRY (Natural) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-629-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/21/2020
    Labeler - KROGER COMPANY (006999528)
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