G-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]

G-TRON PEDIATRIC DROPS (DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL) SOLUTION/ DROPS [KRAMER NOVIS]
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NDC 52083-679-01
Set ID c3881560-a16d-492a-b2f3-032927cf890d
Category HUMAN OTC DRUG LABEL
Packager KRAMER NOVIS
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active Ingredients

    Dextromethorphan HBr,5 mg
    Guaifenesin, 100 mg
    Phenylephrine HCL 2.5 mg

  • Purpose

    Antitussive

    Expectorant

    Nasal Decongestant

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    Non-narcotic cough suppressant which temporarily calms cough due to minor throat and bronchial irritation as may occur with the common cold • calms the cough control center and relieves coughing • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive • temporarily relieves nasal congestion due to the common cold • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

  • Warnings

    Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.

  • Directions

    Do not exceed 6 doses in any 24-hour period, or as directed by physician. Children 6 to under 12 years of age • 2 mL every 4 hours. Children 2 to under 6 years of age, ask a doctor.

  • Other information

    • Tamper Evident Feature: Do not use if cap seal is torn, broken or missing.
    • Store at controlled room temperature 15º-30ºC (59º-86ºF).
    • Avoid excessive heat and humidity.
  • INACTIVE INGREDIENT

    Citric acid, flavor, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution and sucralose.

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for Kramer -Novis, San Juan, PR 00917.

    Tel: (787)767-2072. www.kramernovis.com

  • SPL UNCLASSIFIED SECTION

    * Broncotron® PED Drops is a registered trademark of Seyer Pharmatec.
    This product is not manufactured, distributed or marketed by Seyer Pharmatec.

  • Packaging

    G-TRON Label

  • INGREDIENTS AND APPEARANCE
    G-TRON PEDIATRIC DROPS 
    dextromethorphan hbr,guaifenesin,phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-679
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-679-0130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/09/2014
    Labeler - KRAMER NOVIS (090158395)