Label: BIOCOF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 45737-249-16
  • 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 tps.)        Purpose

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

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

    Phenylephrine HCL.....10 mg...............................................Nasal Decogestant


  • PURPOSE

    Uses:

    • temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants.
    • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

  • WARNINGS

    Warnings:

    Ask a doctor before use if you have:

    • Heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to an enlarged prostate gland
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    Ask a  doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargment or prostate gland
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before useif you are taking any other nasal decongestant or stimulant.

    When using this product do not use more than directed.

    Stop use and ask a doctor if: you get nervous, dizzy, or sleepless; symptoms do not get better within 7 days, or are accompanied by fever

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

    Directions 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

    Uses
    • temporary relives cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to the common cold

  • INACTIVE INGREDIENT

    Inactive Ingredients: Cherry flavor, Citric Acid, Glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucralose

  • QUESTIONS


    Questions or comments? 1-305-403-3788

    Manufactured for: Advanced Generic Corporation
                              Miami, FL 33166

  • PRINCIPAL DISPLAY PANEL

    biocof label

  • INGREDIENTS AND APPEARANCE
    BIOCOF 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-249
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-249-16473 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)