Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE syrup

  • NDC Code(s): 58657-505-08
  • Packager: Method Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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 under 12 yearsDO NOT USE

  • Inactive ingredients

    Citric Acid Anhydrous, USP; Sodium Citrate Dihydrate, USP; Sodium Saccharin, USP; Propylene Glycol, USP; Grape Flavor; Sorbitol Solution, USP; Glycerin, USP; Maltitol Solution, NF

  • Other information

    • store at room temperature 20°-25°C (68°-77°F)
  • Questions

    1-877-250-3427

  • Principal Display Panel

    Method Pharmaceuticals

    NDC 58657-505-08

    Guaifenesin and Dextromethorphan Hydrobromide Syrup

    100 mg/10 mg/5 mL

    Expectorant

    Cough Suppressant

    Grap Flavor

    Non Drowsy • Alcohol Free

    FOR AGES 12 AND UP

    8 fl. oz. (237 mL)

    Manufactured For:

    Method Pharmaceuticals, LLC

    Fort Worth, TX 76118 Rev. 06/2016

    label

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
    guaifenesin and dextromethorphan hydrobromide syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-505
    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)  
    MALTITOL (UNII: D65DG142WK)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-505-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/14/2016
    Labeler - Method Pharmaceuticals (060216698)