Label: ACETAMINOPHEN tablet

  • NDC Code(s): 68001-495-00
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each extended release tablet)

    Acetaminophen USP 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

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

    • more than 6 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

    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.

    • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before ue 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 symptoms 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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right

    away. (1-800-222-1222) 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:

    • take 2 tablets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 tablets in 24 hours
    • do not use for more than 10 days unless directed by a doctor.

    Under 18 years of age:

    • ask a doctor
  • Other information

    • store at 20º to 25ºC (68º to 77ºF). Avoid excessive heat 40ºC (104ºF)
    • do not use if carton is opened or foil inner seal is broken
    • USP Dissolution test is pending
  • Inactive ingredients

    colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline

    cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

  • Questions or comments?

    call 1-855-274-4122

    Manufactured by:
    Aurobindo Pharma Limited
    Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India.

    For BluePoint Laboratories

    Rev: 03/2021

    M.L. No.: 22/MN/AP/2009/F/R

  • Package Label - Principal Display Panel

    Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00

    Carton

    Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00

    Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-495
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite ((White to Off-White)) Scoreno score
    ShapeCAPSULE ((Caplet)) Size19mm
    FlavorImprint Code I;06
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-495-001 in 1 CARTON04/30/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20722904/30/2021
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Ltd650381903analysis(68001-495) , manufacture(68001-495)
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