Label: GENEXA ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated

  • NDC Code(s): 69676-0059-2, 69676-0059-5
  • Packager: Genexa Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take

    • more than 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

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

    Ask a doctor before use if you have liver disease

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    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.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than directed (see Overdose warning)

    adults and children 12 years and over

    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days, unless directed by a doctor

    children under 12 years

    ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each caplet contains: calcium 12 mg
    • store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

    ‡natural

  • QUESTIONS

    Questions? 1-855-436-3921

  • SPL UNCLASSIFIED SECTION

    Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing.

    *This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Tylenol® Extra Strength Caplets.

    Patent Pending | Distributed by: Genexa Inc.

    Atlanta, GA 30318 | genexa.com

    Made in the USA with globally sourced ingredients

    NDC 69676-0059-2

    R-20220323

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    MEDICINE MADE CLEAN

    For Adults

    Acetaminophen Extra Strength

    Pain Reliever Fever Reducer

    Compare to active ingredient in Tylenol® Extra Strength Caplets*

    100 Caplets 500 mg each

    How we're different

    Made without: FD&C red no. 40 aluminum lake, titanium dioxide, propylene glycol & more!

    Acetaminophen Extra Strength 100ct_Carton_R-20220323

  • INGREDIENTS AND APPEARANCE
    GENEXA ACETAMINOPHEN  EXTRA STRENGTH
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0059
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    INULIN (UNII: JOS53KRJ01)  
    ACACIA (UNII: 5C5403N26O)  
    GUAR GUM (UNII: E89I1637KE)  
    AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    RICE BRAN (UNII: R60QEP13IC)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALM OIL (UNII: 5QUO05548Z)  
    Product Characteristics
    Colorwhite (LIGHT BEIGE WITH SPECKLES) Scoreno score
    ShapeOVAL (Oblong) Size18mm
    FlavorImprint Code G4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0059-21 in 1 CARTON02/17/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69676-0059-51 in 1 CARTON02/17/2022
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34302/17/2022
    Labeler - Genexa Inc. (079751024)
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