Label: TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE- dextromethorphan hydrobromide and guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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

  • Active Ingredients

    Dextromethorphan HBr,USP 10 mg
    Guaifenesin, USP 100 mg

    Close
  • Purpose

    Dextromethorphan HBr...................Cough suppressant
    Guaifenesin, USP..............................Expectorant

    Close
  • 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

    Close
  • 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.

    Close
  • 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

    Close
  • When using this product

    • do not use more than directed

    Close
  • 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.

    Close
  • If pregnant or breast-feeding,

    ask a health
    professional before use.

    Close
  • Keep this and all drugs out of the reach of children.

    In case of accidental overdose, seek professional
    assistance or contact a Poison Control Center
    immediately.

    Close
  • Directions

    • do not exceed 6 doses in a 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     2 teaspoonfuls (tsps) every 4 hours
    children under 12 years                              do not use

    Close
  • Other Information

    store at controlled room temperature

    alcohol-free

    sugar-free

    dosage cup provided

    Close
  • Inactive Ingredients

    acesulfame potassium, citric acid, flavors,
    glycerin, methyl paraben, polyethylene glycol,
    povidone, propylene glycol, purified water,
    saccharin sodium, sodium benzoate

    Close
  • Principal Display Panel

    Rite Aid Pharmacy

    Compare to the Active Ingredients in Robitussin Cough and Chest Congestion Sugar-Free DM

    tussin cough and chest congestion DM

    Dextromethorphan HBr, 10 mg

    guaifenesin, 100 mg

    cough suppressant, expectorant

    Sugar-Free

    Non-Drowsy

    Alcohol Free

    Specially formulated for Diabetics

    Relieves- coughs, chest congestion and mucus

    12 years and older

    4 FL Oz (118 mL)

    image of label

    Close
  • INGREDIENTS AND APPEARANCE
    TUSSIN COUGH AND CHEST CONGESTION DM  SUGAR FREE
    robitussin sugar free cough liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0100
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    acesulfame potassium  
    citric acid monohydrate  
    glycerin  
    methylparaben  
    POLYETHYLENE GLYCOL 300  
    povidone  
    propylene glycol  
    saccharin sodium  
    sodium benzoate  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0100-4 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/15/2013
    Labeler - Rite Aid (014578892)
    Registrant - Aaron Industries, Inc. (101896231)
    Establishment
    Name Address ID/FEI Business Operations
    Aaron Industries, Inc. 101896231 manufacture(11822-0100), analysis(11822-0100)
    Close