Label: AXIM DM MAX- dextromethorphan hydrobromide, guaifenesin liquid

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

Drug Label Information

Updated January 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 20 mL)Purposes
    Dextromethorphan HBr 20 mgCough suppressant
    Guaifenesin 400 mgExpectorant
  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • the intensity of coughing
      • the impulse to cough to help you get to sleep
  • 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 or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Do not exceed recommended dosage.

    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

    • do not take more than 6 doses in any 24-hour period
    • this adult strength product is not intended for use in children under 12 years of age
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL = milliliter

    agedose
    adults and children 12 years of age and older20 mL every 4 hours
    children under 12 years of agedo not use

  • Other information

    • each 20 mL contains: sodium 7 mg
    • store at 15-30°C (59-86°F)
    • do not refrigerate
  • Inactive ingredients

    Citric acid, FD&C Blue #1, FD&C red no. 40, flavor, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.

  • SPL UNCLASSIFIED SECTION

    PEEL CORNER TO READ COMPLETE DRUG FACTS AND INFORMATION/ DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    Distributed by:

    VIVUNT PHARMA LLC

    8950 SW 74th Court, Suite 1901

    Miami, FL 33156-3178

    Made in USA

    www.vivunt.live

  • PRINCIPAL DISPLAY PANEL

    Compare to Maximum Strength Mucinex® Fast-Max®

    NDC 82706-013-01

    AXIM - DM MAX

    Cough Relief

    Cough Suppressant
    Expectorant

    Maximum Strength

    Non-Drowsy

    Dextromethorphan HBr

    Guaifenesin

    6 FL OZ (177 mL)

    ADMM

  • INGREDIENTS AND APPEARANCE
    AXIM DM MAX 
    dextromethorphan hydrobromide, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (Intense) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-013-01177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/05/2024
    Labeler - VIVUNT PHARMA LLC (045829437)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rnv LLC118917568manufacture(82706-013)
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