Label: DIABETIC TUSSIN DM MAXIMUM STRENGTH- dextromethorphan hydrobromide and guaifenesin liquid

  • NDC Code(s): 61787-515-04, 61787-515-08
  • Packager: MEDTECH PRODUCTS INC
  • 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 March 3, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each 10 mL)

    Dextromethorphan hydrobromide 20 mg

    Guaifenesin 400 mg

  • Purposes

    Cough Suppressant

    Expectorant

  • Uses

    • temporarily relieves cough caused by the common cold or inhaled irritants.
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus.
  • 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 two 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

    • a cough that occurs with too much phlegm (mucus)
    • a chronic cough that lasts or 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 occurs with fever, rash, or headache that lasts

    These could be signs of a serious condition.

    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

    • take every 4 hours
    • do not exceed 6 doses in 24 hours
    Adults10 mL (2 teaspoons)
    Children under 12 yearsask a doctor
  • Other information

    • store at room temperature 20-25ºC (68-77ºF)
    • keep tightly closed
  • Inactive ingredients

    Acesulfame K, artificial raspberry flavors, hypromellose, menthol, methylparaben, polyethylene glycol, potassium sorbate, purified water and sucralose. Citric acid may be used to adjust pH.

  • Questions or comments?

    Call 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

  • Package Principal Display Panel

    SUGAR & ALCOHOL FREE!

    Specifically Formulated for Diabetics

    Diabetic Tussin®

    MAXIMUM STRENGTH

    COUGH & CHEST CONGESTION

    DM

    Dextromethorphan HBr (Cough Suppressant)

    Guaifenesin (Expectorant)

    Relieves:

    • Mucus
    • Cough
    • Sore throat
    • Chest congestion

    Improved Berry Flavor

    4 FL OZ (118 mL)

    SUGAR & ALCOHOL FREE! Specifically Formulated for Diabetics Diabetic Tussin® MAXIMUM STRENGTH COUGH & CHEST CONGESTION DM Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) Relieves: • Mucus • Cough • Sore throat • Chest congestion Improved Berry Flavor 4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN DM MAXIMUM STRENGTH 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-515
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY (artificial raspberry flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61787-515-041 in 1 BOX02/01/2020
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:61787-515-081 in 1 BOX02/01/2020
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/01/2020
    Labeler - MEDTECH PRODUCTS INC (114707784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn Operating Company LLC (dba Akorn)117696873manufacture(61787-515)
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