OTC Medication Information: Leader 8 Hour Pain Reliever

LEADER 8 HOUR PAIN RELIEVER — acetaminophen tablet, film coated, extended release
Cardinal Health

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)

a dults 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

c hildren 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.

This is the 100 count bottle carton label for Leader Acetaminophen (8 hour) extended-release tablets, USP 650 mg.
(click image for full-size original)

100’s bottle carton

LEADER 8 HOUR PAIN RELIEVER
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-477
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
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
STARCH, PREGELATINIZED CORN
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
POVIDONE
STEARIC ACID
PROPYLENE GLYCOL
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL (capsule shaped) Size 19mm
Flavor Imprint Code cor116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-477-78 100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076200 04/30/2002
Labeler — Cardinal Health (097537435)
Registrant — Ohm Laboratories Inc. (051565745)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 manufacture

Revised: 03/2012 Cardinal Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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