Label: ACETAMINOPHEN 500 MG- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    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 doctor or pharmacist.
    • If you are allergic to acetaminophen or any of the inactive ingredient in this product.
  • ASK DOCTOR

    Ask a doctor before use if you have

    • liver disease
  • ASK DOCTOR/PHARMACIST

    Ask a doctor/pharmacist before use if you are

    • taking the blood thinning drug warfarin
  • 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
    • redness or swelling is present
    • new symptoms occur

    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.

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

  • 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 information

    • store at 20º - 25ºC (68º -77ºF)
  • Inactive ingredients

    Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide

  • Questions or comments?

    Call 1 (718) 337-8733 or visit: support@nuvicare.com 

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tyleno® Extra Strength Caplets.

  • PRINCIPAL DISPLAY PANEL

    PL0201-00 NC-Pain Relief ES (Acetaminophen)-100ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500 MG 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84324-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize17mm
    FlavorImprint Code P500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84324-003-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01307/17/2024
    Labeler - NUVICARE LLC (119257565)
    Registrant - NUVICARE LLC (119257565)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRUECARE BIOMEDIX650526341manufacture(84324-003)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAK Pharma USA109960731pack(84324-003)
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