Label: BIOCOTRON- dextromethorphan, guaifenesin liquid

  • NDC Code(s): 45737-209-16
  • 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

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  • ACTIVE INGREDIENT

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

    Dextromethorphan Hydrobromide 10 mg.................. Cough Suppressant

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

  • PURPOSE

    Purpose

    Cough suppressant

    Expectorant

  • 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, chronic bronchitis, or emphysema.
    When using this product,do not exceed recommended dosage 

    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 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.

  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • DOSAGE & ADMINISTRATION

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

     Age Dose
     adults and children 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
     children 6 years to under 12 years 1 teaspoonful (5 mL) every 4 hours 
     children under 6 years  ask a doctor 

  • INDICATIONS & USAGE

    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
  • INACTIVE INGREDIENT

    Inactive ingredients citric acid, cherry flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Biocotron Label

  • INGREDIENTS AND APPEARANCE
    BIOCOTRON 
    dextromethorphan, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-209
    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
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-209-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2009
    Labeler - Advanced Generic Corporation (831762971)
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