TUSSIN DM SUGAR FREE NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

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  • TUSSIN DM SUGAR FREE NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]

TUSSIN DM SUGAR FREE NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]
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NDC 63868-846-52
Set ID 2338c5c5-485f-415c-bb7d-b3d75dcb9137
Category HUMAN OTC DRUG LABEL
Packager QUALITY CHOICE (Chain Drug Marketing Association)
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each 5 mL, 1 teaspoon)

    Dextromethorphan HBr 10 mg

    Guaifenesin 100 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 make coughs more productive
  • 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

    When using this product,

    do not use more than directed.

    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

    • do not take more than 6 doses in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age
    • measure only with dosing cup provided
    • keep dosing cup with product
    • tsp = teaspoon, mL = milliliter
      age  dose
      adults and children 12 years and over  2 tsp (10 mL) every 4 hours
      children under 12 years  do not use
  • Other information

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

    acesulfame potassium, citric acid, glycerin, methyl paraben, natural & artificial flavor, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate

  • Principal Display Panel

    *Compare to the active ingredients in Robitussin® Peak Cold Sugar-Free Cough & Chest Congestion DM

    Sugar-Free

    Non-Drowsy

    Tussin DM

    Cough & Chest Congestion

    Dextromethorphan HBr  Cough Suppressant

    Guaifenesin  Expectorant

    Relieves:

    Cough

    Mucus

    For Ages 12 & Over

    Alcohol Free

    DM Sugar-Free Formula Specially Formulated for Diabetic Use

    FL OZ (mL)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough & Chest Congestion DM.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

  • Package Label

     Dextromethorphan HBr 10 mg, Guaifenesin 100 mg

    Quality Choice Sugar-Free Non-Drowsy Tussin DM

  • INGREDIENTS AND APPEARANCE
    TUSSIN DM  SUGAR FREE NON DROWSY
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-846
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-846-521 in 1 BOX10/31/201412/30/2022
    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 FINALpart34110/31/201412/30/2022
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
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