Label: BIOSPEC DMX- dextromethorphan, guaifenesin liquid

  • NDC Code(s): 45737-264-16
  • 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 HBr 10 mg.................. Cough Suppressant

    Guaifenesin 187 mg .............................................. Expectorant

  • PURPOSE

    Purpose

    cough suppressant

    expectorant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold

    helps loosen phlegm (mucus) and thin bronchial secretions to make cough 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

    • 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. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DirectionsDo not take more than 8 teaspoonfuls in any 24-hour period

     adults and children 12 years of age and over take 2 teaspoonfuls (10 mL) every 4 hours
     children 6 years to under 12 years of agetake 1 teaspoonful every 4 hours 
     children 2 years to under 6 years of age take 1/2 teaspoonful every 4 hours
     children under 2 years of ageconsult a doctor 

  • OTHER SAFETY INFORMATION

    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 ingredients citric acid, glycerin, methylparaben, natural and artificial flavors, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

  • QUESTIONS

    Questions or comments?1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    BiospecDMX264

  • INGREDIENTS AND APPEARANCE
    BIOSPEC  DMX
    dextromethorphan, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-264
    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) GUAIFENESIN187 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-264-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2015
    Labeler - Advanced Generic Corporation (831762971)