Label: ACETAMIOPHEN- acetaminophen tablet, extended release

  • NDC Code(s): 23155-202-01, 23155-202-18, 23155-202-64, 23155-202-65
  • Packager: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 23, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Active Ingredients (In each caplet)

    Active ingredient (in each caplet)
                                                              Purpose
    Acetaminophen 650 mg
                                  Pain reliever/fever reducer
  • PURPOSE

    Drug Facts

    Active ingredient (in each caplet)

    Acetaminophen 650mg ....................... Pain reliever/fever reducer.

  • Uses

    • temporarily relieves minor aches and pain 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 non-prescription). 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 DOCTOR

    Ask a doctor before use if you have liver disease.

  • ASK DOCTOR/PHARMACIST

    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 if present.

    These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poision Control of 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 of 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:

    • do not use
  • Other information

    • store between 20-25°C (68-77°F)
    • do not use if foil inner seal imprinted with "SAFETY SEAL" is broken or missing.
  • Inactive ingredients

    hydroxyethyl cellulose, maize starch, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, FD&C yellow no. 6 aluminum lake and FD&C yellow no. 10 aluminum lake.

  • Questions or comments?

    Call: 1.866.901.DRUG (3784) (toll-free)

    Manufactured for

    Heritage Pharmaceuticals Inc.,

    Eatontown, NJ 07724

    1.866.901.DRUG (3784)

    Made in India

    Rev.08/16

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton

    carton
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 24 Caplets Label

    label
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 Caplets label

    100 caplets
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20000 Tablets

    20000 tablets
  • INGREDIENTS AND APPEARANCE
    ACETAMIOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23155-202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITE (caplet) Scoreno score
    ShapeCAPSULE (yellow layer and white coloured plain layer) Size19mm
    FlavorImprint Code 511
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23155-202-641 in 1 CARTON06/01/2018
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:23155-202-651 in 1 CARTON06/01/2018
    2750 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:23155-202-011 in 1 CARTON06/01/2018
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:23155-202-1820000 in 1 CONTAINER; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20703506/01/2018
    Labeler - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
    Registrant - Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. (189630168)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micro Labs Limited915793658MANUFACTURE(23155-202)