Label: ACETAMINOPHEN tablet

  • 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 September 5, 2018

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

  • ACTIVE INGREDIENT

    Acetaminophen 500 mg

  • PURPOSE

    Pain Reliever/Fever Reducer

  • INDICATIONS & USAGE

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

    Liver warning:

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

    more than 8 tablets in 24 hours, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    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.

    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 symptom 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.

    Overdose Warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    • do not take more than directed
    • adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
    • children under 12 years: do not use
  • INACTIVE INGREDIENT

    povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • OTHER SAFETY INFORMATION

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    • store at 20⁰C-25⁰C (68⁰F-77⁰F)
    • for institutional use only
  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code M2A457344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-002-1010 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    2NDC:52959-002-1414 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    3NDC:52959-002-1515 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    4NDC:52959-002-2020 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    5NDC:52959-002-2424 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    6NDC:52959-002-2525 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    7NDC:52959-002-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    8NDC:52959-002-4040 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    9NDC:52959-002-4242 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    10NDC:52959-002-4545 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    11NDC:52959-002-5050 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    12NDC:52959-002-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/08/2001
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894manufacture(52959-002) , relabel(52959-002) , repack(52959-002)