Label: SILTUSSIN SA- guaifenesin liquid 

  • Label RSS
  • NDC Code(s): 54838-117-40, 54838-117-70, 54838-117-80
  • 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))

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  • PURPOSE

    Purpose: Expectorant

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  • INDICATIONS & USAGE

    Uses Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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  • Warnings


    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

    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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  • Directions

    • do not take more than 6 doses in any 24-hour period
    • repeat dose every 4 hours

    adults and children 12 years and over
    2-4 teaspoonfuls (TSP)
    children under 12 years DO NOT USE

    Other information

    Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamper evident safety seal around cap is broken or missing.

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  • Inactive ingredients

    citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water.

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  • Questions

    888-974-5279

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave
    Carmel, NY 10512
    USA

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  • INGREDIENTS AND APPEARANCE
    SILTUSSIN SA 
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-117
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    D&C yellow no. 10  
    FD&C blue no. 1  
    FD&C red no. 40  
    glycerin  
    propylene glycol  
    saccharin sodium dihydrate  
    sodium benzoate  
    sodium citrate  
    sorbitol  
    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:54838-117-40 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:54838-117-70 237 mL in 1 BOTTLE, PLASTIC
    3 NDC:54838-117-80 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/05/1998
    Labeler - Silarx Pharmaceuticals, Inc (161630033)
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