BIOCOF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]

BIOCOF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ADVANCED GENERIC CORPORATION]
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NDC 45737-249-16
Set ID 6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6
Category HUMAN OTC DRUG LABEL
Packager Advanced Generic Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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