TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]

TUSNEL (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]
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NDC 54859-502-06, 54859-502-10, 54859-502-16
Set ID 805dc611-355a-4af5-bf19-464c3290c5c6
Category HUMAN OTC DRUG LABEL
Packager Llorens Pharmaceutical International Division
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients(in each 5 ml tsp.)                                  Purpose

    Dextromethorphan HBr........15mg..................................................Cough Suppressant

    Guaifenesin........................200mg................................................Expectorant

    Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant



  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • WARNINGS


    Warnings
    Do not use if you are now taking a prescription monoamine 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of prostate gland
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition
  • 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.

    AgeDose
    Adults and children
    12 years of age and over
     Take 2 teaspoonfuls (10 mL)
     every 6 hours

  • INDICATIONS & USAGE

    Uses:

    • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
    • helps control reflex that causes coughing
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
  • INACTIVE INGREDIENT

    Inactive ingredients: artificial grape flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    tusnelliquidlabel

  • INGREDIENTS AND APPEARANCE
    TUSNEL 
    dextromethorphan, guiafenesin, pseudoephedrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-502
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-502-06178 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    2NDC:54859-502-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    3NDC:54859-502-103786 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2006
    Labeler - Llorens Pharmaceutical International Division (037342305)