Label: GUAIFENESIN DM- guaifenesin and dextromethorphan syrup

  • NDC Code(s): 60687-828-42, 60687-828-48, 60687-828-56
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 4, 2024

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  • Active ingredient (in each 10 mL Cup)

    Guaifenesin 200 mg
    Dextromethorphan Hydrobromide 20 mg

  • Purpose

    Expectorant
    Cough Suppressant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • 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

    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    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.
    • you are hypersensitive to any of the 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

    Follow dosage below or use as directed by a physician.

    • do not take more than 6 doses in any 24-hour period.

    Age (yr)

    Dose (mL)

    adults and children 12 years and over

    10 mL (2 teaspoonfuls) every 4 hours

    children 6 years to under 12 years

    5 mL (1 teaspoonful) every 4 hours

    children 2 years to under 6 years

    2.5 mL (1/2 teaspoonful) every 4 hours

    children under 2 years

    ask a doctor
  • Other Information

    • Each 10 mL contains: sodium 8 mg
    • Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
    • DO NOT USE IF SEAL IS BROKEN.
    • Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup and is available in the following dosage forms:
      5 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-817-17
      10 mL unit-dose cups: 100 cups (10 x 10) NDC 60687-828-56
  • Inactive Ingredients

    citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.

  • Questions or comments?

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    R0324

  • Package/Label Principal Display Panel - Label

    GUAIFENESIN and DEXTROMETHORPHAN SYRUP Label

    Case NDC 60687-828-56/Cup NDC 60687-828-42

    GUAIFENESIN and
    DEXTROMETHORPHAN
    SYRUP

    Expectorant/Cough Suppressant

    200 mg/20 mg per 10 mL

    Non-Narcotic, Alcohol Free
    Cherry Flavor

    Usual Dosage: See attached Drug Facts.

    Store at 20° to 25°C (68° to 77°F) [See USP]
    Protect from light.

    FOR INSTITUTIONAL USE ONLY

    T0638C100324                 R03/24

  • Package/Label Principal Display Panel – Cup Lid – 200 mg/20 mg per 10 mL

    GUAIFENESIN and DEXTROMETHORPHAN SYRUP Cup Lid

    NDC 60687- 828-42

    Guaifenesin and
    Dextromethorphan Syrup

    Expectorant/cough Suppressant

    200 mg/20 mg per 10 mL

    Sodium Content: 8 mg/10 mL

    Delivers 10 mL

    Protect from light

    See package Drug Facts insert for full
    prescribing information and storage

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    F0638C100224

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN DM 
    guaifenesin and dextromethorphan syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-828
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-828-5610 in 1 CASE08/04/2024
    1NDC:60687-828-4810 in 1 TRAY
    1NDC:60687-828-4210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/04/2024
    Labeler - American Health Packaging (929561009)
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