Label: SILTUSSIN DM - guaifenesin and dextromethorphan hydrobromide liquid 

  • Label RSS
  • NDC Code(s): 54838-209-40, 54838-209-70, 54838-209-80
  • Packager: Silarx Pharmaceuticals,Inc
  • 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 06/14

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

  • ACTIVE INGREDIENT

    Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))

    Active Ingredient: Dextromethorphan Hydrobromide 10 mg (in each 5 mL (teaspoon)(TSP))

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  • PURPOSE

    Purpose of Guaifenesin: Expectorant

    Purpose of Dextromethorphan Hydrobromide: Cough Suppressant

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  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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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.

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  • Ask a doctor before use if you have

    • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
    • cough accompanied by excessive phlegm (mucus)
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  • Stop use and ask a doctor if

    • cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
    • hypersensitive to any ingredients
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  • If pregnant or breast-feeding

    • ask a health professional before use.
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  • KEEP OUT OF REACH OF CHILDREN

    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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  • 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

    Adults and children 12 years and over
    2 teaspoonfuls (TSP)
    every 4 hours
    Children under 12 years DO NOT USE
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  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, FD&C red no. 40, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, strawberry flavor, sucrose, purified water.

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  • Other information

    store at room temperature 20°-25°C (68°-77°F)

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  • QUESTIONS

    Questions: 888-974-5279


    Manufactured by

    Silarx Pharmaceutical Inc,

    1033 Stoneleigh Ave.
    Carmel, NY 10512

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  • INGREDIENTS AND APPEARANCE
    SILTUSSIN DM 
    guaifenesin and dextromethorphan hydrobromide liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-209
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    FD&C red no. 40  
    glycerin  
    menthol  
    methylparaben  
    propylene glycol  
    saccharin sodium dihydrate  
    sodium benzoate  
    sucrose  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor STRAWBERRY (STRAWBERRY FLAVOR) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-209-40 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:54838-209-70 237 mL in 1 BOTTLE, PLASTIC
    3 NDC:54838-209-80 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/05/1992
    Labeler - Silarx Pharmaceuticals,Inc (161630033)
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