Label: DEXTROMETHORPHAN HBR AND GUAIFENESIN liquid

  • NDC Code(s): 81033-213-50, 81033-213-51
  • Packager: KESIN PHARMA CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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  • Dextromethorphan HBr and Guaifenesin Oral Solution

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

  • ACTIVE INGREDIENT

     Active Ingredients – 5mL (1 teaspoonful) Purposes
     Guaifenesin 100 mg Expectorant
     Dextromethorphan 5 mg Cough Suppressant

  • Inactive Ingredients

    Trisodium citrate Dihydrate, Citric Acid Anhydrous, USP Xanthan Gum Sodium Benzoate, NF Glycerin 99.7%, USP Propylene Glycol Sucralose Powder Sodium Saccharin, USP Sorbitol Solution 70%, Non-Crystallizable Sodium Artificial Mixed Berry Flavor Purified Water

  • Uses

    ▪ Temporarily relieves cough due to minor throat and bronchial irritations as my occur with a cold
    ▪ Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

  • 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 and 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

    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.

  • PREGNANCY 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.

  • DOSAGE & ADMINISTRATION

    Directions
    ▪ 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

  • SPL UNCLASSIFIED SECTION

    Other information

    • Each teaspoonful contains: sodium 4 mg
    • Store at 20° - 25°C (68° - 77°F)
    • Alcohol/sugar free
    • Clear, mixed berry flavored solutions supplied in the following oral dosage forms: NDC 81033-213-05 (unit dose cups of 5mL) and NDC 81033-213-10 (unit dose cups of 10mL)
  • QUESTIONS

    QUESTIONS OR COMMENTS
    Call 1-833-537-4679

  • PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

    NDC 81033-213-50

    Dextromethorphan HBr and Guaifenesin Oral Solution

    Delivers 5mg/100mg per 5mL

    FOR INSTITUTIONAL USE ONLY

    50 X 5 mL Unit Dose Cups

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

    5 mL cup label

  • PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

    NDC 81033-213-51

    Dextromethorphan HBr and Guaifenesin Oral Solution

    Delivers 10mg/200mg per 10mL

    FOR INSTITUTIONAL USE ONLY

    50 X 10 mL Unit Dose Cups

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

    10 mL cup label

  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HBR AND GUAIFENESIN 
    dextromethorphan hbr and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (Mixed Berry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-213-5050 in 1 CARTON11/15/2023
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:81033-213-5150 in 1 CARTON11/15/2023
    210 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 DrugM01211/15/2023
    Labeler - KESIN PHARMA CORPORATION (117447816)
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