Label: BIOSPEC DMX- dextromethorphan, guaifenesin liquid

  • NDC Code(s): 45737-211-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • ACTIVE INGREDIENT

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

    Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

    Guaifenesin 25 mg .............................................. Expectorant

  • PURPOSE

    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

  • WARNINGS

    Warnings


    • Do not exceed recommended dosage.
    • 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.

    Ask a doctor before use if you have


    • Cough that occurs with too much phlegm (mucus)
    • Cough that lasts or is such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • DO NOT USE

    Stop use and ask a doctor if


    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or accompanied by fever
    • 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.
  • 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.

  • DOSAGE & ADMINISTRATION

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

    adults and children 12 years and over, 1 teaspoonfuls (5 ml) every 4 hours

    children 6 years to under 12 years, 1/2 teaspoonful (2.5 ml) every 4 hours

    children 4 to 6 years, 1/4 teaspoonful (1.25 ml) every 4 hours

    children under 4 years of age, consult a doctor

  • INDICATIONS & USAGE

    Other informationstore at room temperature 15-30 C (59-86 F).

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

  • INACTIVE INGREDIENT

    Inactive ingredientsCherry Flavor, Glycerin, Menthol, Potassium Guaiacol Sulfonate,
    Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Water.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    BiospecDMXLabel

  • INGREDIENTS AND APPEARANCE
    BIOSPEC  DMX
    dextromethorphan, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-211
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN25 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM GUAIACOLSULFONATE (UNII: TTK33Z47F1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-211-16473 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 DrugM01210/01/2009
    Labeler - Advanced Generic Corporation (831762971)