Label: BRONCOTRON - dextromethorphan hydrobromide and guaifenesin liquid 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/11

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

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

    Guaifenesin, 100 mg................................................................................. Expectorant Close
  • 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.
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  • 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.
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  • 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.

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  • 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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • DOSAGE & ADMINISTRATION

    Directions

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

    Age Doses
     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
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  • INDICATIONS & USAGE

    Other information:

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


    Inactive ingrdients:

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

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

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  • INGREDIENTS AND APPEARANCE
    BRONCOTRON 
    dextromethorphan, guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11026-2640
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    CITRIC ACID MONOHYDRATE  
    POLYGLYCERIN-10  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    METHYLPARABEN  
    SODIUM CITRATE  
    WATER  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Cherry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11026-2640-4 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/1998
    Labeler - Seyer Pharmatec, Inc. (832947126)
    Registrant - Seyer Pharmatec, Inc. (832947126)
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