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ACETAMINOPHEN



SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient (in each capsule)

Acetaminophen 325 mg


Purpose

Pain reliever/ fever reducer


Uses

• Temporarily relieves minor aches and pains due to :

     ◦ headache     ◦ muscular aches     ◦ backache     ◦ minor pain of arthritis     ◦ the common cold     ◦ toothache     ◦ premenstrual 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• 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease


OTC - ASK DOCTOR/PHARMACIST SECTION

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

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(seeOverdose warning)

 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 years ask a doctor

Other Information

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat


Inactive ingredients

FD&C red #40, gelatin, sorbitol, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, titanium dioxide, purified water