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

  • NDC Code(s): 51316-434-19
  • Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 3, 2023

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

View All Sections
  • Day

    Active ingredients (in each 20 mL)

    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg

    Purpose

    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)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    cough persists more than 7 days, tends to recur, or is accompanied by a 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.

    Directions

    • do not take more than directed
    • do not take more than 6 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
    • children under 12 years: do not use

    Other information

    • each 20 mL contains: sodium 16 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number

    Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum

    Questions or comments?

    1-800-426-9391

  • Night

    Active ingredients (in each 20 mL)

    Dextromethorphan HBr 30 mg
    Doxylamine Succinate 12.5 mg

    Purpose

    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:
      • itching of the nose or throat
      • itchy, watery eyes
      • runny nose
      • sneezing
    • controls the impulse to cough to help you sleep

    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

    • a cough that occurs with too much phlegm (mucus)
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem or persistent or chronic cough 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 exceed recommended dosage
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    cough persists more than 7 days, tends to recur, or is accompanied by a 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.

    Directions

    • do not take more than directed
    • do not take more than 4 doses in any 24-hour period
    • mL = milliliter
    • only use the dose cup provided
    • adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours
    • children under 12 years: do not use

    Other information

    • each 20 mL contains: sodium 14 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number

    Inactive ingredients

    anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum

  • Principal Display Panel 

    DAY & NIGHT COMBO PACK

    ♥CVS
    Health®

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

    MAXIMUM
    STRENGTH
    MAXIMUM STRENGTH
    FOR MUCUS RELIEF
    Daytime Non-Drowsy
    Tussin DM

    DEXTROMETHORPHAN HBr
    Cough suppressant
    GUAIFENESIN
    Expectorant

    Cough & Chest
    Congestion

    Relieves:
    • Cough
    • Chest congestion
    • Mucus

    Menthol-Berry Flavor
    Dosage cup
    provided
    For Ages
    12 & Over
    Actual Bottle Size
    on Side Panel

    4 FL OZ (118 mL) + 4 FL OZ (118 mL)
    TOTAL 8 FL OZ (236 mL)

    ♥CVS
    Health®

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

    MAXIMUM
    STRENGTH
    MAXIMUM STRENGTH
    Nighttime
    Tussin DM

    DEXTROMETHORPHAN HBr
    Cough suppressant
    DOXYLAMINE SUCCINATE
    Antihistamine

    Cough &
    Antihistamine

    Relieves:
    • Cough
    • Runny nose
    • Sneezing

    Menthol-Berry Flavor
    Dosage cup
    provided

    For Ages
    12 & Over

    Actual Bottle Size
    on Side Panel

    50844 ORG012303004336
    DO NOT TAKE DAYTIME AND NIGHTTIME
    PRODUCTS AT THE SAME TIME
    TAMPER EVIDENT: DO NOT USE IF PRINTED
    NECK WRAP IS BROKEN OR MISSING
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR
    MISSING

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2023 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-19849
    CVS.com/returnpolicy
    100% money back
    guaranteed.

    *This product is not manufactured or distributed
    by GlaxoSmithKline Consumer Healthcare
    Holdings (US) LLC, owner of the registered
    trademarks Robitussin® Maximum Strength
    Cough + Chest Congestion DM and Robitussin®
    Maximum Strength Nighttime Cough DM.

    PARENTS:
    Learn about teen medicine abuse
    www.StopMedicineAbuse.org

    Package Contains Two Bottles
    Actual Size

    CVS 44-030043

    CVS 44-030043

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM  DAYTIME NIGHTTIME
    dextromethorphan hbr, doxylamine succinate, guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-434
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-434-191 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/18/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    TUSSIN DM  DAYTIME
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Item Code (Source)NDC:51316-304
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorred (MAROON) Score    
    ShapeSize
    FlavorMENTHOL, BERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/18/2023
    Part 2 of 2
    TUSSIN DM  NIGHTTIME
    dextromethorphan hbr, doxylamine succinate solution
    Product Information
    Item Code (Source)NDC:51316-430
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Colorred (MAROON) Score    
    ShapeSize
    FlavorMENTHOL, BERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/18/2023
    Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(51316-434) , pack(51316-434)
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!