Label: EQUATE ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release 

  • Label RSS
  • NDC Code(s): 49035-544-01, 49035-544-47, 49035-544-62, 49035-544-78, view more
    49035-544-83, 49035-544-87
  • Packager: Wal-Mart Stores Inc
  • 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 08/14

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

  • Active ingredient (in each caplet)

    Acetaminophen 650 mg

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  • Purpose

    Pain reliever/fever reducer

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  • 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
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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

    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
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  • Other information

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

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    Compare to Tylenol® Arthritis Pain Active Ingredient

    Arthritis Pain

    Acetaminophen Extended-Release Tablets, 650 mg

    Pain Reliever / Fever Reducer

    For the Temporary Relief of Minor Arthritis Pain

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    325 CAPLETS†

    650 mg EACH

    †Capsule-Shaped Tablets

    Actual Size

    Equate Arthritis Pain Image
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  • INGREDIENTS AND APPEARANCE
    EQUATE ARTHRITIS PAIN 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-544
    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
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    POVIDONES  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    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:49035-544-62 1 in 1 CARTON
    1 24 in 1 BOTTLE
    2 NDC:49035-544-78 1 in 1 CARTON
    2 100 in 1 BOTTLE
    3 NDC:49035-544-83 225 in 1 BOTTLE
    4 NDC:49035-544-87 2 in 1 PACKAGE
    4 NDC:49035-544-47 150 in 1 BOTTLE
    5 NDC:49035-544-01 325 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075077 05/16/2000
    Labeler - Wal-Mart Stores Inc (051957769)
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