Label: TUSSIN DM- dextromethorphan hydrobromide and guaifenesin liquid 

  • Label RSS
  • NDC Code(s): 76140-106-08
  • Packager: davAgen Pharmaceutical, LLC
  • 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 12/13

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

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp): Purpose
    Dextromethorphan HBr, USP 10 mg Cough suppressant
    Guaifenesin, USP 100 mg Expectorant
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  • 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.

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  • 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) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

    Do not exceed recommended dose

    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 right away.

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  • Other information

    Each tsp contains: sodium 6.5 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

    Dosage cup provided.

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  • Inactive ingredients

    citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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  • 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
    • mL = milliliter; tsp = teaspoonful
    age dose
    adults and children 12 years and over 10 mL (2 tsp) every 4 hours
    children under 12 years do not use
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  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    davAgen
    Pharmaceutical LLC
    Somerset, NJ 08873

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  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    davAgen
    pharmaceutical

    NDC 76140-106-08

    Adults & Children Ages 12 & Older

    Tussin DM
    Cough &
    Chest Congestion

    Cough Suppressant - Dextromethorphan HBr
    Expectorant - Guaifenesin

    For Relief of:

    • Cough
    • Chest Congestion & Mucus

    8 FL OZ (237 mL)

    Principal Display Panel - 237 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    TUSSIN DM 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76140-106
    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
    Sodium Benzoate  
    Citric Acid Monohydrate  
    Sorbitol  
    Saccharin Sodium  
    Sucralose  
    FD&C Red No. 40  
    Propylene Glycol  
    Glycerin  
    Sodium Citrate  
    Menthol  
    Water  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor TROPICAL FRUIT PUNCH, ORANGE, MENTHOL Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76140-106-08 1 in 1 CARTON
    1 236 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/10/2013
    Labeler - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    Name Address ID/FEI Business Operations
    davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(76140-106), PACK(76140-106), LABEL(76140-106), ANALYSIS(76140-106)
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