G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]

G-TRON PED (DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL) SOLUTION [KRAMER NOVIS]
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NDC 52083-678-16
Set ID 75cd3241-e571-4b50-b03a-1715dc747825
Category HUMAN OTC DRUG LABEL
Packager Kramer Novis
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp)                    Purpose

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

    Guaifenesin, 350 mg..............................................Expectorant

    Phenylephrine HCl, 10 mg................................Nasal decongestant



  • PURPOSE

    Uses
    • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
    • temporarily relieves nasal congestion due to a cold
  • 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.

  • DO NOT USE


    Ask a doctor before use if you have
    • diabetes
    • heart disease
    • thyroid disease
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    When using this product do not use more than directed.

    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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be a signs of a serious condition.
  • PREGNANCY OR BREAST FEEDING


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


  • 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.


  • Directions

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

    EVERY 4 HOURS

    • Adults and Children 12 years of age and older: 5 mL (1 tsp)
    • Children 6 to under 12 years of age: (2.5 mL (1/2 tsp)
    • Children under 6 years of age: Consult physician
  • INDICATIONS & USAGE


    Other information

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

    Store at controlled room temperature 15-30°C (59-86°F).

    Avoid excessive heat and humidity.

  • INACTIVE INGREDIENT


    Inactive ingredients
    Citric acid, flavor, hydroxyethyl cellulose, methyl paraben, potassium citrate, polyethylene glycol, propyl paraben, purified water, sorbitol and sucralose.

  • QUESTIONS

    Manufactured in the USA for Kramer-Novis, San Juan, PR 00917.
    Tel: (787) 767-2072 / www.kramernovis.com

  • Principal Display Panel

    G-TRON® PED

    COUGH SUPPRESSANT

    EXPECTORANT

    NASAL DECONGESTANT

    Contains the same active ingredients as Broncotron® PED

    SUGAR FREE

    DYE FREE

    ALCOHOL FREE

    GRAPE FLAVOR

    16 Fl. Oz. (474 mL)

    KRAMER-NOVIS

    kramer-supress-pe
  • INGREDIENTS AND APPEARANCE
    G-TRON  PED
    dextromethorphan hbr, guiafenesin, phenylephrine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-678
    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) GUAIFENESIN350 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYETHYL CELLULOSE (280 MPA.S AT 5%) (UNII: B24JYI97VR)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-678-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product01/27/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/27/2014
    Labeler - Kramer Novis (090158395)