Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE syrup

  • NDC Code(s): 58657-504-08
  • Packager: Method Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients

    Dextromethorphan HBr, USP 10 mg
    Guaifenesin, USP 100 mg

  • Purpose

    Cough suppressant
    Expectorant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial
      irritation
    • helps loosen phlegm (mucus) and thin bronchial secretions
      to make coughs more productive
  • Warnings

    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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • Ask a doctor before use if you have

    • persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
    • cough accompanied by excessive phlegm (mucus)
  • Stop use and ask a doctor if

    • cough lasts more than 7 days or occurs with fever, rash, or
      headaches that lasts. This could be a sign of a serious condition
    • hypersensitive to any ingredients
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions

    • do not take more than 6 doses in any 24-hour period. This adult product is not intended for use in children under 12 years of age

    adults and children 12 years and over2 teaspoonfuls (TSP) every 4 hours
    children 6 to 12 years of age1 teaspoonful (TSP) every 4 hours
    children under 6 yearsDO NOT USE

  • TAMPER-EVIDENT

    Do not use if seal cap is broken or missing.

  • Inactive ingredients

    Anhydrous citric acid, dextrose, FD&C Red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

  • Other information

    • store at room temperature 20°-25°C (68°-77°F)
    • each 5 mL contains: sodium 3 mg
  • Questions

    1-877-250-3427

  • Principal Display Panel

    Method Pharmaceuticals

    NDC 58657-504-08

    Guaifenesin and Dextromethorphan Hydrobromide Syrup

    100 mg/10 mg/5 mL

    Expectorant

    Cough Suppressant

    Grape Flavor

    Non Drowsy • Alcohol Free

    FOR AGES 12 AND UP

    8 fl. oz. (237 mL)

    Manufactured For:

    Method Pharmaceuticals, LLC

    Southlake, TX 76092 Rev. 02/2024

    label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-504
    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) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-504-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2024
    Labeler - Method Pharmaceuticals (060216698)