TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]

TUSNEL (DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL) TABLET [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]
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NDC 54859-801-60
Set ID a8784c65-47a5-4b72-a85b-fb51cfd22c6c
Category HUMAN OTC DRUG LABEL
Packager LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients (In each tablet)                      Purpose

    Dextromethorphan HBr ................... 30 mg ................... Cough Suppressant

    Guaifenesin .................................. 400 mg .................. Expectorant

    Pseudoephedrine HCl .................... 60 mg .................... Nasal Decongestant


  • PURPOSE

    Uses

    • temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
    • temporary relief of cough due to minor throat and bronchial irritation
    • helps to control reflex that causes coughing
  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to the enlargement of the prostate gland
    • a cough that occurs with too much phlegm (mucus)
    • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or accompanied by fever
    • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache
  • DO NOT USE

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

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions:Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.


    adults and children 12 years of age and over
    take 1 tablet every 6 hours
    children 6 to under 12 years of age
    take 1/2 tablet every 6 hours
    children under 6 years of age
    ask a doctor


  • INDICATIONS & USAGE

    Other Information

    Store at controlled room temperature 20-25 degrees C (68-77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F)

    Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering

  • INACTIVE INGREDIENT

    Inactive Ingredients: FD and C Blue No. 1, FD and C Blue No. 2, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, purified water, sodium starch glycolate type B, titanium dioxide.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    TusnelTabLabel

  • INGREDIENTS AND APPEARANCE
    TUSNEL 
    dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code TUSNEL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-801-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2007
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)