G-TUSS-NL PED (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]

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  • G-TUSS-NL PED (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]

G-TUSS-NL PED (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MCLAREN MEDICAL]
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NDC 43913-406-16
Set ID 0c2632f4-edbc-47d4-94ef-af3512520596
Category HUMAN OTC DRUG LABEL
Packager McLaren Medical
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL, teaspoonful)Purpose
    Guaifenesin 50 mgExpectorant
    Dextromethorphan HBr 5 mgCough Suppressant
    Pseudoephedrine HCI 15 mgNasal Decongestant
  • Indications

    • For the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis).
    • Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
    • Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants.
    • Temporarily helps you cough less.
  • Warnings

    • Do not exceed recommended dosage.
      If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.
    • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

    • Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
    • Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    • A persistent cough may be the sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache, consult a doctor.

    • Do not take this product for persistent or chronic cough such as occurs with asthma or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

    • In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    • Keep this and all drugs out of the reach of children.
  • Directions

    Do not take more than 6 doses in any 24-hour period.

    Children 6 to under 12 years of age2 teaspoonfuls (10 mL) every 4 hours
    Children 2 to under 6 years of age1 teaspoonful (5 mL) every 4 hours
    Children under 2 years of ageConsult a doctor
  • Inactive Ingredients

    Citric Acid, Grape Flavor, Propylene Glycol, Purified Water, Saccharine Sodium, Sodium Benzoate, Sorbitol, Sucralose.

  • Other Information

    Store at 20°-25°C (68°-77°F)

    Tamper evident by seal under cap. Do not use if the seal is broken or missing.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC-43913-406-16

    G-Tuss-NL Ped

    Cough Suppressant, Expectorant & Nasal Decongestant

    Sugar Free • Dye Free • Alcohol Free • Phenylalanine Free

    Grape Flavor

    16 FL OZ (473 mL)

    Multiple Dose Unit Package
    For Dispensing Under Pharmaceutical Supervision Only

    McLaren Medical

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    G-TUSS-NL PED 
    dextromethorphan hydrobromide, guaifenesin, and pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43913-406
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin50 mg  in 5 mL
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sorbitol (UNII: 506T60A25R)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43913-406-16473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/11/2014
    Labeler - McLaren Medical (013770591)
    Registrant - davAgen Pharmaceutical, LLC (967545935)
    Establishment
    NameAddressID/FEIBusiness Operations
    davAgen Pharmaceutical, LLC967545935MANUFACTURE(43913-406) , PACK(43913-406) , LABEL(43913-406) , ANALYSIS(43913-406)
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