Label: TUSNEL EX- guaifenesin liquid

  • NDC Code(s): 54859-507-04
  • Packager: Llorens Pharmaceutical International Division, Inc.
  • 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 July 10, 2022

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  • ACTIVE INGREDIENT

    In each 5 mL

    Guaifenesin - 100 mg

  • PURPOSE

    Purpose

    Expectorant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • WARNINGS

    Warnings

    Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

    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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeing, ask a health professional before use.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions: Do not exceed more than 6 doses in any 24-hour period.

     Age Dose
     Adults and children over 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
     Children under 12 years Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a sucralose.

  • QUESTIONS

    Questions or comments? 1-8660595-5598

  • PRINCIPAL DISPLAY PANEL

    TusnelEX

  • INGREDIENTS AND APPEARANCE
    TUSNEL  EX
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-507
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-507-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2019
    Labeler - Llorens Pharmaceutical International Division, Inc. (037342305)
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