Label: ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG- acetaminophen tablet, extended release

  • NDC Code(s): 25000-071-02, 25000-071-08, 25000-071-10, 25000-071-11, view more
    25000-071-45, 25000-108-02, 25000-108-08
  • Packager: MARKSANS PHARMA LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 17, 2023

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  • Active ingredient (in each caplet)

    Acetaminophen 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain

    • 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.

    Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain

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

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

    • more than 6 caplets 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 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 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 and children 12 years and over 
    • take 2 caplets every 8 hours with water
    • swallow whole; do not crush, chew, split, or dissolve
    • do not take more than 6 caplets in 24 hours
    • do not use for more than 10 days unless directed by a doctor 
     children under 12 years
    •  ask a doctor.

    Other information

    • store between 20-25°C (68-77°F)
    • The FDA approved Dissolution methods differ from USP
    • do not use if carton is opened. Do not use if foil inner seal is broken or missing


  • Inactive ingredients

    carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

    Questions or comments ?
    Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST

  • PRINCIPAL DISPLAY PANEL

    NDC 25000-071-02
    Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain
    24 count carton label


    aceta-24s-carton


    NDC 25000-071-02
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    24 count bottle label


    aceta-24s-label


    NDC 25000-071-08
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    100 count carton label


    aceta-100s-carton


    NDC 25000-071-08
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    100 count bottle label


    aceta-100s-label


    NDC 25000-071-10
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    225 count carton label


    aceta-225s-carton


    NDC 25000-071-10
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    225 count bottle label


    aceta-225s-label


    NDC 25000-071-11
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    290 count carton label


     

    aceta-290s-carton

    NDC 25000-071-11
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    290 count bottle label


     

    aceta-290s-label


    NDC 25000-071-45
    Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain
    400 count bottle label


    aceta-400s-label


    NDC 25000-108-02
    Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
    24 count carton label


    aceta-musclepain-24s-carton


    NDC 25000-108-02
    Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
    24 count bottle label


    aceta-musclepain-24s-label


    NDC 25000-108-08
    Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
    100 count carton label


    aceta-musclepain-100s-carton


    NDC 25000-108-08
    Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain
    100 count bottle label


    aceta-muscle-100s-label


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-071
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    Product Characteristics
    ColorWHITE (White to off white) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-071-021 in 1 CARTON09/02/2021
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:25000-071-081 in 1 CARTON09/02/2021
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:25000-071-101 in 1 CARTON09/02/2021
    3225 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:25000-071-111 in 1 CARTON09/02/2021
    4290 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:25000-071-45400 in 1 BOTTLE; Type 0: Not a Combination Product09/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21548609/02/2021
    ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 MG 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-108
    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)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    Product Characteristics
    ColorWHITE (white to off white) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25000-108-021 in 1 CARTON10/14/2022
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:25000-108-081 in 1 CARTON10/14/2022
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21548610/14/2022
    Labeler - MARKSANS PHARMA LIMITED (925822975)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-071, 25000-108)
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