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Acetaminophen Extended Release (NCS HealthCare of KY, Inc dba Vangard Labs)

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TABLET 30 TABLET in 1 BLISTER PACK (0615-7590-39) Label Information

Complete Acetaminophen Extended Release Information

  • 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 650mg

    Acetaminophen ER Tab 650mg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN EXTENDED RELEASE 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-7590(NDC:0904-5769)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE (caplet) Size 19mm
    Flavor Imprint Code L544
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0615-7590-39 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075077 02/25/2000
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    Name Address ID/FEI Business Operations
    NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK(0615-7590)