Label: ACETAMINOPHEN- acetaminophen tablet, extended release

  • NDC Code(s): 37205-662-57, 37205-662-58
  • Packager: Cardinal Health
  • 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 01/13

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

  • ACTIVE INGREDIENT (IN EACH GELTAB)

    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:
      • muscular aches
      • backache
      • headache
      • toothache
      • the common cold
      • minor pain of arthritis
      • premenstrual and menstrual cramps
    • temporarily reduces fever
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  • 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.

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  • 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
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  • 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.
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  • 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

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  • QUESTIONS?

    Call 1-800-406-7984

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  • 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).
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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-662
    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
    CROSCARMELLOSE SODIUM  
    GELATIN  
    GLYCERIN  
    HYPROMELLOSES  
    FERROSOFERRIC OXIDE  
    FERRIC OXIDE YELLOW  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONE  
    STARCH, PREGELATINIZED CORN  
    PROPYLENE GLYCOL  
    SODIUM LAURYL SULFATE  
    STARCH, CORN  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white (White to Yellow) Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code 350
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-662-58 40 in 1 BOTTLE
    2 NDC:37205-662-57 80 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078569 12/21/2012
    Labeler - Cardinal Health (097537435)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(37205-662)
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