Label: MAX TUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin liquid

  • NDC Code(s): 71399-0025-4, 71399-0025-6, 71399-0025-8
  • Packager: Akron Pharma 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 May 15, 2023

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 10 mL)

    Dextromethorphan HBr 20 mg

    Guaifenesin 200 mg

  • Purposes

    Cough suppressant

    Expectorant

  • 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 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 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

    If pregnant or breast-feeding,

    ask a health professional before 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.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • keep dosing cup with product
    • mL= milliliter
    • this adult product is not intended for use in children under 12 years of age
     age dose
     adults and children 12 years and over 10 mL every 4 hours
     children under 12 years do not use

  • Other information

    • Phenylketonurics: contains Phenylalanine 30 mg per 10 mL
    • store between 20-25ºC(68-77ºF). Do not refrigerate
  • Inactive ingredients

    anhydrous citric acid, flavor cherry, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucralose, sucrose.

  • Questions or comments?

    toll-free 1-877-225-6999

    Manufactured for:

    Akron Pharma, Inc.

    Fairfield, NJ 07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAX TUSSIN COUGH AND CHEST CONGESTION DM 
    dextromethorphan hbr, guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0025
    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) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0025-41 in 1 PACKAGE05/15/2023
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:71399-0025-81 in 1 PACKAGE05/15/2023
    2236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:71399-0025-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34105/15/2023
    Labeler - Akron Pharma Inc. (067878881)