TUSSIN DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [CVS PHARMACY]

TUSSIN DM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [CVS PHARMACY]
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NDC 59779-145-04, 59779-145-08
Set ID 1ae825b9-327e-4d21-a7cc-b65de83ea2ba
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 30 mg

    Doxylamine succinate 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 sedate a child or 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

    • glaucoma 
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or 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 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 more than 7 days, comes back, or is accompanied by 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 (1-800-222-1222) right away.

  • Directions

    • this adult product is not intended for use in children under 12 years of age
    • do not take more than 4 doses in any 24-hour period
    • measure only with dosing cup provided. Do not use any other dosing device.
    • keep dosing cup with product
    • mL = milliliter
    • adults and children 12 years and over: 10 mL every 6 hours
    • children under 12 years: do not use

  • Other information

    • store between 20-25°C (68-77°F). Do not refrigerate.
  • Inactive ingredients

    anhydrous citric acid, FD&C red #40, flavors glycerin, high fructose corn syrup, menthol, polyethylene glycol 300, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

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

    MAXIMUM STRENGTH

    Nighttime 

    Tussin DM

    DEXTROMETHORPHAN HBr, 30 mg Cough suppressant

    DOXYLAMINE SUCCINATE, 12.5 mg Anthihistamine

    Adult Cough & Antihistamine

    Relieves:

    • Cough
    • Itchy throat
    • Runny nose

    For Ages 12 Years & Over

    Alcohol Free

    Dosage cup provided

    FL OZ (mL)

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    CVS.com®  1-800-SHOP-CVS

    Product of U.S.A.

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Maximum Strength Nighttime Cough DM.

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    PARENTS: Learn about teen medicine abuse

  • Package Label

    Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

    CVS Health Nighttime Tussin DM Maximum Strength

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM  MAXIMUM STRENGTH
    dextromethorphan hbr, doxylamine succinate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 10 mL
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-145-041 in 1 BOX05/31/201412/29/2023
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59779-145-081 in 1 BOX05/31/201412/29/2023
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/31/201412/29/2023
    Labeler - CVS Pharmacy (062312574)

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