Label: UP AND UP NIGHTTIME COUGH CONTROL DM MAX- dextromethorphan hbr, doxylamine succinate solution

  • 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 December 13, 2019

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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?

    1-888-547-7400

  • Package/Label Principal Display Panel

    see new dosing

    Compare to active ingredients in Robitussin® Maximum Strength Nighttime Cough DM

    maximum strength

    nighttime cough control DM MAX

    dextromethorphan HBr (cough suppressant)

    doxylamine succinate (antihistamine)

    relieves cough, itchy throat and runny nose

    for adults

    AGES 12 + YEARS

    8 FL OZ (237 mL)

    nighttime-cough-control-dm-max-image
  • INGREDIENTS AND APPEARANCE
    UP AND UP NIGHTTIME COUGH CONTROL DM MAX 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-719
    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 (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL (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:11673-719-341 in 1 CARTON09/26/2018
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/26/2018
    Labeler - Target Corporation (006961700)
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