Label: BRONCOTRON- dextromethorphan, guaifenesin liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 28, 2011

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  • ACTIVE INGREDIENT

    Active ingredients(in each 5 mL teaspoonful) .......................................... Purpose

    Dextromethorphan HBR, 10 mg..................................................................Cough suppressant

    Guaifenesin, 100 mg................................................................................. Expectorant
  • PURPOSE

    Uses:

    • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold.
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
  • WARNINGS

    Warnings:

    Ask a doctor before use if you have:

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, bronchitis, or emphysema.
    Stop use and ask a doctor if:

    • Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • DO NOT USE

    Do not use if you are now taking a prescription monoamine oxidase (MOAI) (certain drugs for depression, pychiatric, or emotional conditions, or Parkison'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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the 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 care professional before use.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24-hour period, unless directed by a physician.

    AgeDoses
     adults and children 12 years and over
     2 teaspoonfuls every 4 hours
     children 6 years to under 12 years
     1 teaspoonful every 4 hours
     children under 6 years
     ask a doctor
  • INDICATIONS & USAGE

    Other information:

    • Phenylketonuric: contains Phenylalanine 35mg/5mL
    • store at room temperature.
  • INACTIVE INGREDIENT


    Inactive ingrdients:

    Aspartame, citric acid, flavor, glycerine, hydroxyethyl cellulose, methylparaben, propyparaben, sodioum citrate, water.
  • QUESTIONS

    Questions or Comments call: 1(800) 782- 3585.

  • PRINCIPAL DISPLAY PANEL

    broncotronlabel

  • INGREDIENTS AND APPEARANCE
    BRONCOTRON 
    dextromethorphan, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2640
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYGLYCERIN-10 (UNII: P9060O936A)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11026-2640-4118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1998
    Labeler - Seyer Pharmatec, Inc. (832947126)
    Registrant - Seyer Pharmatec, Inc. (832947126)