Label: BIO-Z-COUGH- dextromethorphan hydrobromide, guaifenesin liquid

  • NDC Code(s): 45737-251-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL

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 tps.)        Purpose

    Dextromethorphan Hydrobromide.... 20 mg...........................Cough suppressant

    Guaifenesin.... 400 mg........................................................Expectorant


  • PURPOSE


    Uses:

    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
    • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
  • 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, chronic bronchitis, or emphysema.


    When using this product do not use more than directed.

    Stop use and ask a doctor before use if:

    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.


  • DO NOT USE


    Do not use:

    If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs of 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 MAOI; ask your doctor or pharmacist before taking this product.


  • 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.

  • PREGNANCY OR BREAST FEEDING

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

  • DOSAGE & ADMINISTRATION

    Direction: do not exceed more than 6 doses in any 24 hours period.

    Adults and children 12 years of age and over.
    		 Take 1 teaspoonful (5 mL) every 4 hours
    Children under 12 years of age.
    		 Consult a physician
  • INDICATIONS & USAGE


    Other Information:
    • Store at room temperature 15 - 30 degrees celsius (59 - 86 degrees farenheit)
    • Tamper evident feature Do not use if seal under cap is torn, broken or missing.
    • Avoid excessive heat or humidity.



  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Citric Acid, eucalyptus oil, menthol, methylparaben, propylparaben, propylene glycol, sodium citrate, polyethylene glycol, grape flavor, sucralose, and purified water.

  • QUESTIONS


    Questions or comments? 1-305-403-3788

    Manufactured for: Advanced Generic Corporation
    Miami, FL 33166

    www.advancedgeneric.com

  • PRINCIPAL DISPLAY PANEL

    biozcof labelbiozcof label

  • INGREDIENTS AND APPEARANCE
    BIO-Z-COUGH 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-251
    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) GUAIFENESIN400 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (grape flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-251-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/01/2012
    Labeler - Advanced Generic Corporation (831762971)
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