Label: MAX TUSSIN MUCUS AND CHEST CONGESTION- guaifenesin liquid

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

Drug Label Information

Updated November 15, 2023

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  • Active ingredients (in each 10 mL)

    Guaifenesin 200 mg

  • Purposes

    Expectorant

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • Warnings

    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.

    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 (1-800-222-1222).

  • Directions

    • do not take more than 6 doses in any 24-hour period
    • measure only with dosing cup provided
    • 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 - 20 mL every 4 hours
     children under 12 years do not use

  • Other information

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

    anhydrous citric acid, flavor cherry, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, 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

    8Oz

  • INGREDIENTS AND APPEARANCE
    MAX TUSSIN MUCUS AND CHEST CONGESTION 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0054-81 in 1 PACKAGE11/03/2023
    1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/03/2023
    Labeler - Akron Pharma Inc. (067878881)
    Registrant - HI-TECH PHARMACEUTICALS PRIVATE LIMITED (862584260)
    Establishment
    NameAddressID/FEIBusiness Operations
    HI-TECH PHARMACEUTICALS PRIVATE LIMITED862584260manufacture(71399-0054)
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