Label: ACETAMINOPHEN tablet

  • NDC Code(s): 69396-140-01, 69396-140-03
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 12, 2024

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  • Active Ingredient

    Acetaminophen USP, 500mg (in each tablet)

  • Purpose

    Pain Releiver / Fever Reducer

  • 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.

  • Uses

    Temporarily relieves minor aches and pains due to

    Common cold

    headache

    minor pain of arthritis

    toothache

    muscular aches

    premenstrual and menstrual cramps

    temporarily relieves fever

  • Warnings

    Liver warning

    This product contains acetaminophen. Sever liver damage may occur if you take

    • more than 4000mg 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 ad seek medical medical help right away

  • 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.

  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    Do not take more than directed. See overdose warning

    Adults and children 12 years and older

    • Take 2 tablets every 6 hours while symptoms last
    • Do not take more than 6 tablets 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 of age

    • Ask a doctor
  • 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 a sign of a serious condition

  • If pregnant or breast-feeding

    Ask a health professional before use

  • Overdose Warning

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

  • Other Information

    • Store at 20ºC - 25ºC (68ºF - 77ºF)
    • Avoid high humidity
    • See end panel for expiration date and lot number
  • Inactive Ingredients

    hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycoate, Stearic Acid

  • Questions or Comments?

    Call 1-888-296-9067

  • Distributed By:

    Distributed By:

    Trifecta Pharmaceuticals USA®

    Ft. Lauderdale, FL. 33301 USA

    1-888-296-9067

    *This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol®

    Reorder No. 2004

    Made in the USA

  • Label

    CS 2004 Globe Acetaminophen 500mg 50pk 030624 CDER

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-140
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code G552
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-140-0310000 in 1 BAG08/08/2023
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69396-140-0150 in 1 BOX08/08/2023
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01308/08/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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