Label: BRONCOTRON D- guaifenesin, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 

  • Label RSS
  • 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


    Guaifenesin 200 mg........................................................................... Expectorant

    Dextromethorphan HBr 20 mg............................................................ Cough Suppressant

    Phenylephrine HCL 5 mg.................................................................. Nasal Decongestant

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  • PURPOSE

    Uses

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
    • Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold.
    • Temporarily relieves nasal congestions due to the common cold.
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  • WARNINGS

    Warnings

    Ask the doctor before if you have:

    • heart disease
    • high blood pressure
    • thyroid
    • diabetes
    • trouble urinating due to 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 exceed recommended dosage.
    Stop use and ask a doctor if:

    • your child gets nervous, dizzy, or sleepless.
    • condition lasts for more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
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  • DO NOT USE

    Do not use

    if you are now taking a prescription monoamine pxidase inhibitor (MAOI), (certain drugs for depression, psychiatric, or emotional conditions, or Parkison's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your description drug contains an MAOI, ask a doctor or pharmacist before taking this product. Close
  • 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 immediately.

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  • PREGNANCY OR BREAST FEEDING


    If pregnant or breastfeeding, ask a health care professional before use.

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  • DOSAGE & ADMINISTRATION

    Directions: SHAKE WELL BEFORE USE

    •      do not take more than 3 doses in any 24 hour period

     Age
     Dose
     adults and children 12 years and over
     take 2 teaspoonfuls every 8 hours
     children 6 years to under 12 years
     1 teaspoonful every 8 hours
     children 2 years to under 6 years
     1/2 teaspoonful every 8 hours
     children under 2 years
     do not use


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  • INDICATIONS & USAGE

    Other Information:

    • Warning: Phenylketonurics: Contains phenylalanine 15 mg per 5 mL
    • Store at 15-30 degree celsius(59-86 degree farenheit)
    • Alcohol Free and Phenylpropanolamine(PPA) Free
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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aspartame, cherry flavor, citric acid, glycerin, hydroxyethyl cellulose, kaolin, magnesium aluminium silicate, methylparaben, propylparaben, purified water, sodium citrate, sorbitol. Close
  • QUESTIONS

    Any questions or comments, please call toll-free: 1-888-782-3585

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  • INGREDIENTS AND APPEARANCE
    BRONCOTRON  D
    guaifenesin, dextromethorphan, phenyphrine hydrchloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11026-2681
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
    KAOLIN  
    MAGNESIUM ALUMINUM SILICATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    WATER  
    SODIUM CITRATE  
    SORBITOL  
    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:11026-2681-4 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/01/2007
    Labeler - SEYER PHARMATEC, INC. (832947126)
    Registrant - SEYER PHARMATEC, INC. (832947126)
    Establishment
    Name Address ID/FEI Business Operations
    Lex Inc. 046172888 manufacture
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