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

  • 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.

View All Sections
  • Active ingredients (in each 20 mL) - NIGHTTIME

    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?

    1-800-719-9260

  • Active ingredients (in each 20 mL) - DAYTIME

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg

  • Purposes

    Cough suppressant

    Expectorant

  • 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
  • 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).

  • 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
  • Other information

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

  • 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
  • INGREDIENTS AND APPEARANCE
    TUSSIN DM MAX DAYTIME NIGHTTIME 
    dextromethorphan hbr, doxylamine succinate, guaifesesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-929
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-929-121 in 1 CARTON; Type 0: Not a Combination Product07/20/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    TUSSIN DM 
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:69842-699
    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:69842-699-261 in 1 CARTON
    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 finalpart34106/25/2018
    Part 2 of 2
    TUSSIN DM 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Item Code (Source)NDC:69842-819
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorREDScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-819-261 in 1 CARTON
    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 finalpart34105/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/20/2018
    Labeler - CVS Pharmacy (062312574)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!