Label: DIABETIC SILTUSSIN DAS-NA- guaifenesin liquid

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

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 March 27, 2018

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

  • ACTIVE INGREDIENT

    Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoonful) (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.

    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 teaspoonfuls (TSP)
     Children under 12 years
     DO NOT USE

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

    Phenylketonurics: contains phenylalanine 3 mg per teaspoonful (5 mL)

  • Inactive Ingredients

    Acesulfame-K, aspartame, benzoic acid, citric acid, hydroxypropyl methyl cellulose, methylparaben, propylene glycol, strawberry flavor, and water.

  • Questions

    1-844-834-0530

    Manufactured by:

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

    10-1048       Rev. 03/18


  • PRINCIPAL DISPLAY PANEL

    118 mL
  • INGREDIENTS AND APPEARANCE
    DIABETIC SILTUSSIN DAS-NA 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-138
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRY (strawberry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54838-138-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/05/2005
    Labeler - Lannett Company, Inc. (161630033)