Leader Extra Strength Acetaminophen (acetaminophen 500 mg) Dailymed

Drug Facts

Active Ingredient (in Each Softgel)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take â–  more than 4,000 mg of acetaminophen in 24 hours â–  with other drugs containing acetaminophen â–  3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: â–  skin reddening â–  bulers â–  rash If a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

â–  with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. â–  if you are allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor Section

Ask a doctor before use if you have liver disease

Otc - Ask Doctor/pharmacist Section

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - Stop Use Section

â–  pain gets worse or lasts more than 10 days â–  fever gets worse or lasts more than 3 days â–  new symptoms occur â–  redness or swelling is present These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children Section

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 softgels every 6 hours while symptoms last ■ do not take more than 6 softgels in 24 hours unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor
 children under 12 years	 ask a doctor

Other Information

■ each softgel contains: sodium 7 mg ■ store between 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol 400, potassium hydroxide, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol, sorbitol sorbitan solution titanium dioxide

Otc - Questions Section

Questions or Comments? 1-888-333-9792

Principal Display Panel

Leaderâ„¢ Extra Strength Acetaminophen

Compare to the active ingredient in Tylenol® Extra Strength* Liquid-Filled Capsules**

EXTRA STRENGTH Acetaminophen USP 500mg

Pain Reliever; Fever reducer Aspirin free 40 SOFTGELS** **Liquid filled capsules

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

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

Distributed by: CARDINAL HEALTH DUBLIN, OHIO 43017 Made in India CIN 5546221