Label: ACETAMINOPHEN tablet, extended release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 16, 2013

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  • ACTIVE INGREDIENT (IN EACH GELTAB)

    Acetaminophen USP, 650 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    • temporarily relieves minor aches and pains due to:
      • muscular aches
      • backache
      • headache
      • toothache
      • the common cold
      • minor pain of arthritis
      • premenstrual and menstrual cramps
    • temporarily reduces fever
  • WARNINGS

    Liver warning: This product contains acetaminophen. Sever 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

    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

    • do not take more than directed (see overdose warning)
      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.
    • 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, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    NDC 37205-662-58

    LEADER®

    Compare to Tylenol Arthritis Pain active ingredient†

    Use only as directed.

    Lasts up to 8 hours

    Arthritis Pain Reliever

    Acetaminophen Extended-Release Tablets, USP 650 mg

    Pain Reliever/Fever Reducer

    For the Temporary Relief of Minor Arthritis Pain

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    40 GELTABS*650 mg EACH

    *Gelatin-Coated Tablets

    DISTRIBUTED BY CARDINAL HEALTH

    5099022/1012

    This is the 40 count bottle carton label for Leader Acetaminophen extended-release tablets, USP 650 mg (geltabs).
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-662
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White to Yellow) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code 350
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-662-5840 in 1 BOTTLE
    2NDC:37205-662-5780 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07856912/21/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(37205-662)
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