Label: PURGENLABS ACETAMINOPHEN- actaminophen liquid

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

Drug Label Information

Updated June 28, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredient

    in each 15 mL Tablespoonful

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Liver Warning:This product contains acetaminophen. The maximurr
    daily dose of fhis product is 6 tablespoonfuls in 24 hours.
    Severe liver damage may occur if you take
    • more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24
    hours • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert acetaminophen may cause severe skin reactions.
    Symptoms may include: • skin reddening • blisters • rash
    If a skin reaction occurs, stop use and seek medical help right away.

  • DO NOT USE

    Do not use • with any other drug containing acetaminophen
    (prescription or nonprescription). If you are not sure whether a drug
    contains acetaminophen, ask a octor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive
    ingredients in this product

    Ask a doctor before use ff rou have liver disease.
    Ask a doctor before use ff you are taking the blood thinning
    drug wartarin.
    When using this product Do not exceed recommended dose.

  • STOP USE

    Stop use and ask a doctor If • pain gets worse or lasts more than
    10 days • fever gets worse or lasts more than 3 days • new
    symptoms occur • redness or swelling is present.
    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. 

  • DOSAGE & ADMINISTRATION

     AgeDose 
     adults and children 12 years of age and olderTake 1 to 2 Tablespoonfuls every 4 to 6 hours as needed; not more than 6 tablespoonsfuls in 24 hours 
     children under 12 years Do not use 

  • INACTIVE INGREDIENT

    Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

  • QUESTIONS

    Questions or comments? call toll free 1-800-630-8895

  • PRINCIPAL DISPLAY PANEL

    APAP

  • INGREDIENTS AND APPEARANCE
    PURGENLABS ACETAMINOPHEN 
    actaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-230
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80513-230-081 in 1 CARTON06/01/2024
    1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2024
    Labeler - Advanced Rx LLC (042795108)