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Acetaminophen (Walgreen Company)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED, EXTENDED RELEASE 150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-0334-55) Label Information

Complete Acetaminophen Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient (in each caplet)

    Acetaminophen USP, 650 mg


  • 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 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.


  • Directions

    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).
    • see end panel for batch number and expiration date
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

  • Inactive ingredients

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


  • Questions?

    call 1-800-406-7984


  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015


  • PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

    Walgreens

    Compare to Tylenol® 8 HR
    Arthritis Pain active ingredient††

    NDC 0363-0334-22

    Arthritis
    Pain Reliever

    ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP, 650 mg /
    PAIN RELIEVER / FEVER REDUCER

    ARTHRITIS
    8 HOUR
    CAPLETS

    • For the temporary relief of minor arthritis pain
    • Lasts up to 8 hours

    ACTUAL SIZE

    225
    CAPLETS*
    (*CAPSULE-SHAPED TABLETS)

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    USE ONLY AS DIRECTED

    PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0334
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    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:0363-0334-55 150 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002
    2 NDC:0363-0334-22 225 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2002
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076200 04/30/2002
    Labeler - Walgreen Company (008965063)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 MANUFACTURE(0363-0334)