Label: ACETAMINOPHEN tablet, extended release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 15, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each geltab)

    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 geltabs 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
    • 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
    • the tablet got stuck in your throat

    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 geltabs every 8 hours. Swallow only one geltab at a time.
    • take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 geltabs 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 high humidity.
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • Inactive ingredients

    croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch (corn), 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 Geltab Bottle Label

    Walgreens

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

    EASY-OPEN

    NDC 0363-0340-08

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

    ARTHRITIS 8 HOUR

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

    ACTUAL SIZE

    80 GELTABS* (*GELATIN-COATED TABLETS)

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    PRINCIPAL DISPLAY PANEL - 650 mg Geltab Bottle Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0340
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White to Yellow) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code 350
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0340-0880 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07856905/01/2016
    Labeler - Walgreen Company (008965063)
    Registrant - Ranbaxy Pharmaceuticals Inc. (947890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(0363-0340)
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