Label: BIOBRON DX- dextromethorphan, guaifenesin, phenylephrine liquid

  • NDC Code(s): 45737-246-16
  • Packager: Advanced Generic Corporation
  • 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

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

  • ACTIVE INGREDIENT

    Active Ingredients: (in each 5 mL tsp.)              Purpose

    Dextromethorphan Hydrobromide 20 mg.................. Cough Suppressant

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

    Phenylephrine HCl 10 mg.................................. Nasal Decongestant

  • PURPOSE


    Uses

    • Temporarily relieves these symptoms, due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
    • Cough due to minor throat and bronchial irritation
    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive
    • Nasal congestion
    • Reduces swelling of nasal passages.
  • WARNINGS

    Warnings

    • Do not exceed recommended dosage
    • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
    • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
    • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
  • DO NOT USE

    Do not Use

    • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor  
    • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.

    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 you are taking a prescription drug that contains an MAOI;
    ask your doctor or pharmacist before taking this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of 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 professional before use.

  • DOSAGE & ADMINISTRATION


    Directions Do not exceed 6 doses in 24 hours.

     adults and children
     12 years of age and over
     take 1 teaspoonful (5 mL)
     every 4 hours
    children 6 to under
     12 years of age
     take 1/2 teaspoonful (2.5 mL)
     every 4 hours
     children under 6 years of age

     ask a doctor



  • INDICATIONS & USAGE

    Other information  store at room temperature 15 - 30 degrees celcius (59 - 86 degrees farhenheits).

    Tamper Evident Feature:
    Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

  • QUESTIONS

    Questions or comments? 1-305-403-3788
    Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
    www.advancedgeneric.com

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, propylene glycol, methylparaben, propylparaben, citric acid, sodium citrate, saccharin calcium,
    cherry flavor, purified water.

  • PRINCIPAL DISPLAY PANEL

    BiobronDXLabel

  • INGREDIENTS AND APPEARANCE
    BIOBRON  DX
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-246
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide20 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-246-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2009
    Labeler - Advanced Generic Corporation (831762971)