Label: TOPCO ARTHRITIS 8 HOUR - acetaminophen tablet, film coated, extended release

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/12

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

  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Acetaminophen USP, 650 mg

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  • PURPOSE

    Pain reliever/fever reducer

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  • USES

    • temporarily relieves minor aches and pains due to:
      • muscular aches
      • headache
      • minor pain of arthritis
      • backache
    • temporarily reduces fever
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  • 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

    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.

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  • 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
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  • OTHER INFORMATION

    • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
    • see end panel for batch number and expiration date
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
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  • INACTIVE INGREDIENTS

    Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

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  • QUESTIONS?

    call 1-888-423-0139

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  • PRINCIPAL DISPLAY PANEL

    TopCare®

    NDC 36800-228-01

    FOR UP TO 8 HOUR RELIEF OF MINOR MUSCLE ACHES & PAIN

    Lasts up to 8 - Hour

    Pain Relief

    ACETAMINOPHEN EXTENDED-RELEASE TABLETS, USP 650 mg

    Pain Reliever/Fever Reducer

    Use only as directed.

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    COMPARE TO TYLENOL®8 HOUR active ingredient††

    100 CAPLETS650 mg EACH

    (CAPSULE-SHAPED TABLETS)

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    5095195/R512

    This is the 100 count bottle carton label for Topco Acetaminophen extended-release tablets, USP 650 mg.
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  • INGREDIENTS AND APPEARANCE
    TOPCO ARTHRITIS 8 HOUR  
    acetaminophen tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:36800-228
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POVIDONE  
    STARCH, PREGELATINIZED CORN  
    PROPYLENE GLYCOL  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape OVAL (Capsule Shaped) Size 19mm
    Flavor Imprint Code cor116
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-228-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076200 04/30/2002
    Labeler - Topco Associates LLC (006935977)
    Registrant - Ohm Laboratories Inc. (051565745)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(36800-228)
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