Label: CARE ONE ARTHRITIS PAIN RELIEF- acetaminophen tablet, film coated, extended release 

  • Label RSS
  • NDC Code(s): 41520-966-78
  • Packager: American Sales Company
  • 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 04/10

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:
    • arthritis
    • the common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • menstrual cramps
    • 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

    • if you are allergic to acetaminophen
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    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: Taking more than the recommended dose (overdose) may cause liver damage. 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 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 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    EASY TO OPEN CAP

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    TEMPORARY, MINOR

    ARTHRITIS PAIN RELIEF

    Acetaminophen Extended-Release Tablets, 650 mg/Pain Reliever - Fever Reducer

    LASTS UP TO 8 HOURS

    See New Warnings Information

    650 mg EACH

    *Capsule-Shaped Tablets

    Arthritis Pain Relief Label Image 1

    Arthritis Pain Relief Label Image 1

    Arthritis Pain Relief Label Image 2

    Arthritis Pain Relief Label Image 2

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  • INGREDIENTS AND APPEARANCE
    CARE ONE ARTHRITIS PAIN RELIEF 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-966
    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  
    COLLOIDAL SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 80  
    POVIDONE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code L544
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-966-78 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075077 12/15/2009
    Labeler - American Sales Company (809183973)
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