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ACETAMINOPHEN



Drug Facts


Active ingredient (in each softgel)

Acetaminophen 325 mg


Purpose

Pain reliever/fever reducer


Uses

  • temporarily relieves minor aches and pains due to:
  • headachemuscular achesbackacheminor pain of arthritisthe common coldtoothachepremenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 the user has liver disease


Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin


Stop use and ask a doctor if

These could be signs of a serious condition.

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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

adults and children 12 years and overtake 2 softgels every 4 to 6 hours while symptoms lastdo not take more than 10 softgels in 24 hoursdo not use for more than 10 days unless directed by a doctor
children 6-11 yearstake 1 softgel every 4 to 6 hours while symptoms lastdo not take more than 5 softgels in 24 hoursdo not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor
  • do not take more than directed (see Overdose warning)

Other information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink