Label: MEIJER NITETIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate solution

  • NDC Code(s): 79481-6921-2
  • Packager: MEIJER DISTRIBUTION INC
  • 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 April 19, 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.

    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 as occurs with smoking, asthma, or emphysema
    ▪
    trouble urinating due to an 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

     

    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, 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.

    Questions or comments?

    1-866-467-2748

  • Package/Label Principal Display Panel

    Compare to the active ingredients in VICKS® Nyquil™COLD & FLU NIGHTTIME RELIEF*

    Nitetime

    Cold & Flu

    Relief

    PAIN RELIEVER/FEVER REDUCER, COUGH SUPPRESSANT

    ANTIHISTAMINE

    Acetaminophen,

    Dextromethorphan HBr,

    Doxylamine Succinate

    RELIEVES: HEADACHE, FEVER, SORE THROAT

    MINOR ACHES & PAINS

    SNEEZING, RUNNY NOSE, COUGH

    Mixed Berry

    Naturally and Artificially Flavored

    12 FL OZ (354 mL)

    DIST. BY

    MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    *This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Nyquil™COLD & FLU Nighttime Relief*

    Meijer Nitetime Cold and Flu Relief
  • INGREDIENTS AND APPEARANCE
    MEIJER NITETIME COLD AND FLU RELIEF 
    acetaminophen, dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-6921
    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
    ColorRED (clear dark red) Score    
    ShapeSize
    FlavorBERRY (Mixed Berry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-6921-2354 mL in 1 BOTTLE; Type 0: Not a Combination Product03/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/2023
    Labeler - MEIJER DISTRIBUTION INC (006959555)
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