Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet

  • NDC Code(s): 63629-1516-0, 63629-1516-1, 63629-1516-2, 63629-1516-3, view more
    63629-1516-4, 63629-1516-5, 63629-1516-6, 63629-1516-7, 63629-1516-8, 63629-1516-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 57896-201
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 2, 2024

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  • Active Ingredients

    Acetaminophen 500 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    • 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 (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.

    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.

    Keep out of reach of children. 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.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over: Take 1 to 2 tablets every 4 to 6 hours, as needed; not more than 6 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor
    • children under 12 years: ask a doctor
  • Other Information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • Inactive Ingredients

    povidone, sodium starch glycolate, starch, stearic acid.

  • Questions or comments?

    1-800-540-3765

  • HOW SUPPLIED

    NDC: 63629-1516-1: 20 Tablets in a BOTTLE

    NDC: 63629-1516-2: 15 Tablets in a BOTTLE

    NDC: 63629-1516-3: 40 Tablets in a BOTTLE

    NDC: 63629-1516-4: 100 Tablets in a BOTTLE

    NDC: 63629-1516-5: 30 Tablets in a BOTTLE

    NDC: 63629-1516-6: 45 Tablets in a BOTTLE

    NDC: 63629-1516-7: 50 Tablets in a BOTTLE

    NDC: 63629-1516-8: 60 Tablets in a BOTTLE

    NDC: 63629-1516-9: 90 Tablets in a BOTTLE

    NDC: 63629-1516-0: 250 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Acetaminophen 500 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-1516(NDC:57896-201)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUND (Round) Size12mm
    FlavorImprint Code M2A457344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-1516-120 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2008
    2NDC:63629-1516-215 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
    3NDC:63629-1516-340 in 1 BOTTLE; Type 0: Not a Combination Product12/29/2004
    4NDC:63629-1516-4100 in 1 BOTTLE; Type 0: Not a Combination Product02/21/2006
    5NDC:63629-1516-530 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2007
    6NDC:63629-1516-645 in 1 BOTTLE; Type 0: Not a Combination Product08/11/2009
    7NDC:63629-1516-750 in 1 BOTTLE; Type 0: Not a Combination Product09/10/2008
    8NDC:63629-1516-860 in 1 BOTTLE; Type 0: Not a Combination Product10/09/2008
    9NDC:63629-1516-990 in 1 BOTTLE; Type 0: Not a Combination Product12/21/2010
    10NDC:63629-1516-0250 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/01/1989
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-1516) , RELABEL(63629-1516)
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