TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]

TUSNEL C (CODEINE PHOSPHATE, GUIAFENESIN, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]
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NDC 54859-520-16
Set ID 403935ac-5111-4f8b-80ae-1bd47ae774c7
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

    Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant

    Guaifenesin .......................................................... 100 mg .................. Expectorant

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

  • PURPOSE

    Uses
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
    • temporarily restores freer breathing through the nose
    • calms the cough control center and relieves coughing
  • 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.

    When using this product
    do nol exceed recommended dosage
    • may cause or aggravate constipation

  • DO NOT USE


    Ask a doctor before use if you have
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus) 
    • a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs
    Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless. symptoms do not get better within 7 days or are accompanied by fever. cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. 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 helpor 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: Follow dosage chartDosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose
    than recommended by a doctor could result in serious side effects for your child. A special measuring
    device should be used to give an accurate dose of this product to children under 6 years of age.

    AgeWeightDose
    children 12 years of age and over95 lbs and up Take 2 teaspoonfuls (10 mL)
     every 6 hours
    Children 6 to under 12 years of age45 lbs to under 95 lbs Take 1 teaspoonful (5mL)
     every 6 hours
    Children under 6 years of ageunder 45 lbs ask a doctor

  • INDICATIONS & USAGE


    Other information
    • store at controlled room temperature 20°- 25°C (68°- 77°F)
    • Each teaspoonful (5 ml) contains: sodium 2mg
    • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
  • INACTIVE INGREDIENT

    Inactive ingredients aspartame, citric acid, glycerine, methylparaben,
    natural and artificial flavors, potassium citrate, potassium sorbate,
    propylene glycol, propylparaben, purified water.

  • QUESTIONS

    Questions or Comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    tusnelclabeltusnelclabel

  • INGREDIENTS AND APPEARANCE
    TUSNEL  C
    codeine phosphate, guiafenesin, pseudoephedrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-520
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin100 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-520-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1995
    Labeler - Llorens Pharmaceutical International Division (037342305)