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Leader 8 Hour Pain Reliever

Dosage form: tablet, film coated, extended release
Ingredients: ACETAMINOPHEN 650mg
Labeler: Cardinal Health
NDC Code: 37205-477

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:
    • muscular aches
    • backache
    • headache
    • minor pain of arthritis
  • 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

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
  • do not take more than directed (see overdose warning)

adults and children 12 years and over:

  • 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

children under 12 years:

  • do not use

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

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/label and stand-alone labels only)

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages)

Contains No Aspirin

Keep the carton. It contains important information.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

LEADER®

NDC 37205-477-78

Use only as directed.

Lasts up to 8 Hour Pain Reliever

Acetaminophen Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

For up to 8 Hour Relief of Minor Muscular Aches & Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

100 CAPLETS* 650 mg EACH

*Capsule-Shaped Tablets

Compare to Tylenol® 8 Hour active ingredient**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc. The owner of the registered trademark Tylenol® is The Tylenol Company.

100's bottle carton

LEADER 8 HOUR PAIN RELIEVER  
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-477
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
STARCH, PREGELATINIZED CORN 
SODIUM LAURYL SULFATE 
MAGNESIUM STEARATE 
CROSCARMELLOSE SODIUM 
POVIDONE 
STEARIC ACID 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (capsule shaped) Size19mm
FlavorImprint Codecor116
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-477-78100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Cardinal Health (097537435)
Registrant - Ohm Laboratories Inc. (051565745)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture

Revised: 03/2012
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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