Label: SILTUSSIN SA- guaifenesin liquid

  • NDC Code(s): 54838-117-40, 54838-117-70, 54838-117-80
  • Packager: Lannett Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 11, 2021

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    Purpose: Expectorant

  • INDICATIONS & USAGE

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

  • 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.

  • 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.

  • Inactive ingredients

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

  • Questions

    1-844-834-0530

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

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

  • PRINCIPAL DISPLAY PANEL


    118 mL

  • INGREDIENTS AND APPEARANCE
    SILTUSSIN SA 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (strawberry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54838-117-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/199812/31/2024
    2NDC:54838-117-70237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/199809/30/2024
    3NDC:54838-117-80473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/199811/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/05/199812/31/2024
    Labeler - Lannett Company, Inc. (002277481)
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