Label: GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE syrup

  • NDC Code(s): 58657-505-08
  • Packager: Method Pharmaceuticals
  • 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 February 11, 2020

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  • 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

    PDP

  • 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 finalpart34106/14/2016
    Labeler - Method Pharmaceuticals (060216698)
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