Label: BRONCOTRON PED- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops

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

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 23, 2020

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  • ACTIVE INGREDIENT

    Active Ingredients                 Purpose

    (in each 1 mL)



    Dextromethorphan HBr 5 mg ...... Cough Suppressant

    Guaifenesin 100 mg .................... Expectorant

    Phenylephrine HCl 2.5 mg ............. Nasal Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    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 decongest sinus openings and passages; temporarily relieves sinus congestions and pressure
    • 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
  • WARNINGS

    Warnings

    • do not exceed recommended dosage
    • a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.
    Ask a doctor before use if a child has
    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or empgysema, or where cough is accompanied by excessive phlegm (mucus), unless directed by a doctor
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occur
    • if symptoms do not improve within 7 days or are accompanied by fever
    Ask a doctor before use if a child is taking sedatives or tranquilizers.
  • DO NOT USE

    Do not use this in a child who is

    • taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two 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 reach of children. In case of accidental overdose, seek professional  help or contact a Poison Control Center immediately.


  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Directions
    • take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a physician

    Children 6 to under 12 years of age
    2 mL
    Children 2 to under 6 years of age
    Ask a doctor
    Children under 2 years of age
    Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    Citric acid, flavor, magnasweet, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose, xanthan gum

  • QUESTIONS

    Questions or comments 1-888-782-3585

  • PRINCIPAL DISPLAY PANEL

    broncotronpeddrops

  • INGREDIENTS AND APPEARANCE
    BRONCOTRON PED 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11026-2790
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11026-2790-21 in 1 CARTON12/15/2012
    160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/15/2012
    Labeler - Seyer Pharmatec, Inc. (832947126)