Label: TUSSIN DM MAX DAYTIME NIGHTTIME- dextromethorphan hbr, doxylamine succinate, guaifesesin

  • NDC Code(s): 69842-699-26, 69842-819-26, 69842-929-12
  • Packager: CVS Pharmacy
  • 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 18, 2018

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 20 mL) - NIGHTTIME

    Dextromethorphan HBr, USP 30 mg

    Doxylamine succinate, USP 12.5 mg

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  • Purposes

    Cough suppressant

    Antihistamine

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  • 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
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  • 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).

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  • 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

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  • Other information

    each 20 mL contains: sodium 11 mg
    store at 20-25°C (68-77°F)
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  • 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

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  • Questions or comments?

    1-800-719-9260

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  • Active ingredients (in each 20 mL) - DAYTIME

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

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  • Purposes

    Cough suppressant

    Expectorant

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  • Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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  • Warnings

    Do not use

    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

    cough that occurs with too much phlegm (mucus)
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    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).

    Close
  • Directions

    do not take more than 6 doses in any 24-hour period
    measure only with dosing cup provided
    keep dosing cup with product
    mL = milliliter
    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 4 hours

    children under 12 years

    do not use

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  • Other information

    each 20 mL contains: sodium 13 mg
    store at 20-25°C (68-77°F). Do not refrigerate.
    Close
  • Inactive Ingredients

    acetic acid, anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum

    Questions or comments?

    1-800-719-9260

    Close
  • Package/Label Principal Display Panel

    DAY & NIGHT COMBO PACK

    Compare to the active ingredients in Robitussin® Maximum Strength Cough + Chest Congestion DM

    MAXIMUM STRENGTH

    MAXIMUM STRENGTH FOR MUCUS RELIEF

    Non-Drowsy

    See New Dosing

    Tussin DM

    DEXTROMETHORPHAN HBr

    Cough suppressant

    GUAIFENESIN

    Expectorant

    Adult Cough & Chest Congestion

    Relieves:

    Cough

    Chest congestion

    Mucus

    Alcohol free

    Raspberry & Menthol Flavor

    For Ages 12 & Over

    Dosage cup provided

    Actual Bottle Size on Side Panel

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

    MAXIMUM STRENGTH

    Nighttime

    See New Dosing

    Tussin DM

    DEXTROMETHORPHAN HBr

    Cough suppressant

    DOXYLAMINE SUCCINATE

    Antihistamine

    Adult Cough & Antihistamine

    Relieves:

    Cough

    Itchy throat

    Runny nose

    Alcohol free

    Raspberry, Blackberry & Menthol Flavor

    For Ages 12 & Over

    Dosage cup provided

    Actual Bottle Size on Side Panel

    4 FL OZ (118 mL) + 4 FL OZ (118 mL)

    TOTAL 8 FL OZ (236 mL)

    Tussin DM Day and Night Carton Image 1
    Tussin DM Day and Night Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    TUSSIN DM MAX DAYTIME NIGHTTIME 
    dextromethorphan hbr, doxylamine succinate, guaifesesin kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-929
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-929-12 1 in 1 CARTON; Type 0: Not a Combination Product 07/20/2018
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BOTTLE 118 mL
    Part 2 1 BOTTLE 118 mL
    Part 1 of 2
    TUSSIN DM 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Item Code (Source) NDC:69842-699
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg  in 20 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score     
    Shape Size
    Flavor FRUIT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-699-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/25/2018
    Part 2 of 2
    TUSSIN DM 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Item Code (Source) NDC:69842-819
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg  in 20 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor FRUIT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-819-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/04/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/20/2018
    Labeler - CVS Pharmacy (062312574)
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