Label: MEIJER MAXIMUM STRENGTH NIGHTTIME COUGH DM- dextromethorphan hydrobromide, doxylamine succinate solution

  • NDC Code(s): 41250-758-04
  • Packager: MEIJER DISTRIBUTION INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 ml)Purposes

    Dextromethorphan HBr, USP 30 mg

    Cough suppressant

    Doxylamine Succinate, USP 12.5 mg

    Antihistamine
  • Uses

    ▪
    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    ▪
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    ▪
    runny nose
    ▪
    sneezing
    ▪
    itchy, watery eyes
    ▪
    itching of the nose or throat
    ▪
    controls the impulse to cough to help you sleep
  • Warnings

    Do not use

    ▪
    to sedate a child or to make a child sleepy
    ▪
    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

    ▪
    trouble urinating due to an enlarged prostate gland
    ▪
    glaucoma
    ▪
    a 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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    ▪
    do not use more than directed
    ▪
    marked drowsiness may occur
    ▪
    avoid alcoholic drinks
    ▪
    alcohol, sedatives, and tranquilizers may increase drowsiness
    ▪
    be careful when driving a motor vehicle or operating machinery
    ▪
    excitability may occur, especially in children

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

  • Directions

    •
    measure only with dosing cup provided
    •
    keep dosing cup with product
    •
    mL = milliliter
    •
    do not take more than 4 doses in any 24-hour period
    •
    this adult product is not intended for use in children under 12 years of age
    agedose

    adults and children 12 years and over

    20 ml every 6 hours

    children under 12 years

    do not use
  • Other information

    ▪
    each 20 ml contains: sodium 14 mg
    ▪
    store at room temperature.
  • Inactive ingredients

    anhydrous citric acid, FD&C Red #40, flavor, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    meijer®

    NDC 41250-758-04

    Compare to Robitussin® Maximum Strength Nighttime Cough DM active ingredient*

    For Ages 12 & Over


    adult nighttime cough DM

    DEXTROMETHORPHAN HBr 30mg/20mL (Cough Suppressant)
    DOXYLAMINE SUCCINATE 12.5mg/20mL (Antihistamine)

    MAXIMUM STRENGTH

    Nighttime

    RELIEF OF: Cough, Itchy Throat, Runny Nose

    4 FL OZ (118 mL)

    *This product is not manufactured or distributed by Pfizer Inc, distributor of Robitussin.®

    Maximum Strength claim based on maximum levels of active ingredient per dose.

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    MEIJER PHARAMACISTS RECOMMENDED

    MONEY BACK GUARANTEE

    meijer adult nighttime cough DM Maximum Strength
  • INGREDIENTS AND APPEARANCE
    MEIJER MAXIMUM STRENGTH NIGHTTIME COUGH DM 
    dextromethorphan hydrobromide, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-758
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-758-041 in 1 CARTON03/14/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01003/14/2017
    Labeler - MEIJER DISTRIBUTION INC (006959555)
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