EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]

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EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [BRYANT RANCH PREPACK]
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NDC 63629-1516-0, 63629-1516-1, 63629-1516-2, 63629-1516-3, 63629-1516-4, 63629-1516-5, 63629-1516-6, 63629-1516-7, 63629-1516-8, 63629-1516-9
Set ID 31a97a6a-e5c8-429a-b497-330f0d84777d
Category HUMAN OTC DRUG LABEL
Packager Bryant Ranch Prepack
Generic Name
Product Class
Product Number
Application Number PART343
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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 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.

  • Directions

    • 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
  • Other 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
  • Inactive Ingredients

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


  • HOW SUPPLIED

    Product: 63629-1516

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

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

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

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

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

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

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

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

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

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

  • Acetaminophen 500mg Tablet

    Label Image
  • 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)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUND (Round) Size12mm
    FlavorImprint Code M2A457344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-1516-215 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    2NDC:63629-1516-120 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    3NDC:63629-1516-530 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    4NDC:63629-1516-340 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    5NDC:63629-1516-645 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    6NDC:63629-1516-750 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    7NDC:63629-1516-860 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    8NDC:63629-1516-990 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    9NDC:63629-1516-4100 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    10NDC:63629-1516-0250 in 1 BOTTLE; Type 0: Not a Combination Product11/07/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/1989
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-1516) , RELABEL(63629-1516)
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