Extra Strength Pain Reliever

Cardinal Health

Leader 44-148

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Extra Strength Pain Reliever Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Ask a doctor or pharmacist before use if you are
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Extra Strength Pain Reliever Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Extra Strength Pain Reliever Uses

• temporarily relieves minor aches and pains due to:

  • headache

  • the common cold

  • backache

  • minor pain of arthritis

  • toothache

  • muscular aches

  • premenstrual and menstrual cramps

• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• 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.

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 tablets every 4 to 6 hours while symptoms last

  • do not take more than 8 tablets in 24 hours

  • do not take for more than 10 days unless directed by a doctor

• children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Extra Strength Pain Reliever Other information

• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

• see end flap for expiration date and lot number

Inactive ingredients

corn starch, povidone, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

1-800-426-9391 

Principal Display Panel

NDC 37205-659-78

LEADER®

Compare to Extra Strength Tylenol® active ingredient†

EXTRA STRENGTH
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
Contains No Aspirin

100 TABLETS

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.
50844   ORG021314812

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
CIN 1059773
www.myleader.com
1-800-200-6313

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING