Label: DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 30, 2025

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  • Dextromethorphan HBr and Guaifenesin Oral Solution 5 and 10 mL

    Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

    DM Guaifenesin
    Non-Narcotic, Sugar, Dye and Alcohol Free
    Cough Suppressant/Expectorant

  • DESCRIPTION

    Each 5 mL (1 teaspoonful) contains:
    Dextromethorphan Hydrobromide 10 mg
    Guaifenesin 100 mg
    Each 10 mL (2 teaspoonfuls) contains:
    Dextromethorphan Hydrobromide 20 mg
    Guaifenesin 200 mg

  • Inactive Ingredients

    Inactive Ingredients: citric acid, grape flavor, methylparaben, monoammonium glycrrhizate, potassium citrate, propylene glycol, propylparaban,purified water, sorbitol, sucralose.

  • USES

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

    • 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

    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

    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.

    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)

  • DIRECTIONS

    DIRECTIONS

    Follow dosage table below or use as directed by a
    physician

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

    AgeDose
    adults and children 12 years and over10mL (2 teaspoonful) every 4 hours
    children 6 to under 12 years of age5mL (1 teaspoonful) every 4 hours
    children 2 to under 6 years of age2.5mL (1/2 teaspoonful) every 4 hours
    children under 2 yearsconsult a doctor

  • HOW SUPPLIED

    Dextromethorphan hydrobromide and Guaifenesin is a clear, grape flavor solution supplied in the following oral dosage forms:
    5 mL unit dose cup:
    NDC 81033-103-05
    Case containing 100 units dose cups of 5 mL:
    NDC 81033-103-50

    10 mL unit dose cups:
    NDC 81033-103-10
    Case containing 100 unit dose cups of 10 mL:
    NDC 81033-103-51

  • STORAGE

    Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

  • QUESTIONS OR COMMENTS

    QUESTIONS OR COMMENTS
    Call 1-833-537-4679

    Packaged by:
    Kesin Pharma
    Oldsmar, FL 34677
    Effective 10/2024
    Revision 03

    Kesin Pharma Logo

  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

    NDC 81033-103-05

    Dextromethorphan HBr and Guaifenesin Oral Solution

    Delivers 10mg/100mg per 5mL

    FOR INSTITUTIONAL USE ONLY

    Store at 59°F to 86°F (15°C to 30°C)

    NDC 81033-104-05

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

    NDC 81033-103-10

    Dextromethorphan HBr and Guaifenesin Oral Solution

    Delivers 20mg/200mg per 10mL

    FOR INSTITUTIONAL USE ONLY

    Store at 59°F to 86°F (15°C to 30°C)

    NDC 81033-104-05

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION 
    dextromethorphan hbr and guaifenesin oral solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-103(NDC:84447-102)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SORBITOL (UNII: 506T60A25R)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-103-50100 in 1 CASE12/02/2024
    1NDC:81033-103-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:81033-103-51100 in 1 CASE12/02/2024
    2NDC:81033-103-1010 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 DrugM01212/02/2024
    Labeler - KESIN PHARMA CORPORATION (117447816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma Corporation117447816repack(81033-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kesin Pharma Corporation119132647repack(81033-103)
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