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

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

Drug Label Information

Updated September 7, 2017

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

  • Drug Facts

    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:
      • 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

    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 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

    • Supplied as unit dose packages of 30 (5 x 6) NDC 68084-777-25
    • store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F).
    • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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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?

    • about Acetaminophen, USP 650 mg call Ranbaxy Pharmaceuticals, Inc. at 1-800-406-7984
    • about the packaging call American Health Packaging at 1-800-707-4621

    Contains No Aspirin

    PACKAGING INFORMATION
    American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows:
    (650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333

    Distributed by: American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

    8277725/0216OS

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  • Principal Display Panel – Carton – 650 mg

    650 mg Acetaminophen ER Tablets Carton

    NDC 68084-777-25

    Acetaminophen
    Extended-release Tablets, USP
    Pain Reliever/Fever Reducer

    DO NOT USE WITH OTHER MEDICINES
    CONTAINING ACETAMINOPHEN.

    650 mg

    30 Tablets (5 x 6)

    Drug Facts
    Active Ingredient                                          Purpose
    (in each caplet)
    Acetaminophen USP, 650 mg            Pain reliever/fever reducer

    Uses
    See package insert for complete Drug Facts information.

    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.

    Keep out of reach of children.

    See package insert for additional Drug Facts warnings.

    Directions
    • do not take more than directed, see package insert for
    overdose warning and complete Drug Facts information.

    Other Information• store at 20° to 25°C (68° to
    77°F). Avoid excessive heat 40°C (104°F). • FOR YOUR
    PROTECTION: Do not use product if blister is torn or
    broken.

    Contains No Aspirin

    The drug product contained in this package is
    from NDC # 51660-333, Ohm Laboratories Inc.

    Distributed by: American Health Packaging,
    2550 John Glenn Avenue, Suite A, Columbus,
    OH 43217

    077725
    0277725/0216OS

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  • Principal Display Panel – Blister – 650 mg

    650 mg Acetaminophen Er Tablet Blister

    Acetaminophen
    Extended-release
    Tablet, USP
    Pain Reliever/
    Fever Reducer

    650 mg

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  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEVER 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68084-777(NDC:51660-333)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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:68084-777-25 30 in 1 BOX, UNIT-DOSE 08/18/2014
    1 NDC:68084-777-95 1 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 ANDA076200 08/15/2014
    Labeler - American Health Packaging (929561009)
    Establishment
    Name Address ID/FEI Business Operations
    American Health Packaging 929561009 repack(68084-777)
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