Label: BIOSPEC DMX- dextromethorphan, guaifenesin liquid

  • NDC Code(s): 45737-264-16
  • 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

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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

    Directions Do 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 information store at room temperature 15-30 C (59-86 F).

    Tamper Evident Feature Do 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 finalpart34103/01/2015
    Labeler - Advanced Generic Corporation (831762971)
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