Label: TUSNEL EX- guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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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

  • HOW SUPPLIED

    Product: 50090-6542

    NDC: 50090-6542-0 118 mL in a BOTTLE

  • guaifenesin liquid

    Label Image
  • INGREDIENTS AND APPEARANCE
    TUSNEL  EX
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6542(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:50090-6542-0118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2019
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-6542)
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