Label: TOPCARE TUSSIN DM MAX- dextromethorphan hydrobromide, doxylamine succinate solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

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  • Active ingredients (in each 20 mL)

    Dextromethorphan HBr, USP 30 mg

    Doxylamine succinate, USP 12.5 mg

  • Purposes

    Cough suppressant

    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 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
    cough that occurs with too much phlegm (mucus)
    a breathing problem such as emphysema or chronic bronchitis
    persistent or chronic cough such as occurs with smoking, asthma, 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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (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

    age

    dose

    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 11 mg
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    anhydrous citric acid, benzoic acid, benzyl alcohol, carboxymethylcellulose sodium, FD&C blue #1, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    TopCare® health

    COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH NIGHTTIME COUGH DM ACTIVE INGREDIENTS

    NIGHTTIME

    Tussin DM Max

    Nighttime Cough DM

    COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr

    ANTIHISTAMINE – DOXYLAMINE SUCCINATE

    MAXIMUM STRENGTH

    RELIEVES:

    • Cough

    • Itchy Throat

    • Runny Nose

    Adult For Ages 12 & Over

    4 FL OZ (118 mL)

    RASPBERRY, BLACKBERRY & MENTHOL FLAVOR

    6w6-88-nighttime-tussin-dm-max
  • INGREDIENTS AND APPEARANCE
    TOPCARE TUSSIN DM MAX 
    dextromethorphan hydrobromide, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-788
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-788-261 in 1 CARTON05/02/2019
    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 DrugM01205/02/2019
    Labeler - Topco Associates LLC (006935977)