Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 27, 2019

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  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 650mg

  • 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 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 for more than 10 days

        •    fever gets worse or lasts for 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 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

    Under 18 years of age:

    		•ask a doctor
  • Other information

        •    store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).

  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide.

  • Questions or comments?

    1-800-719-9260

    U.S. Patent 7,897,172

    Gluten Free

    Distributed by: MAJOR® PHARMACEUTICALS

    31778 Enterprise Drive, Livonia, MI 48510 USA

    M-05 REV. 10/14

  • Principal Display Panel

    Acetaminophen Extended-Release Tablets 650 mg

    Principal Display Panel Acetaminophen ER 60 mg
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN EXTENDED RELEASE 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-7590(NDC:0904-5769)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L544
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0615-7590-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product04/07/201006/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07507702/25/200006/30/2023
    Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
    Establishment
    NameAddressID/FEIBusiness Operations
    NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-7590)
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