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
  • 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 April 5, 2023

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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 500mg 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 not finalpart34301/01/1989
    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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