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0220K- Major


Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg


OTC - PURPOSE SECTION

Purpose

Pain reliever/ Fever reducer


Uses

Temporarily reduces fever and relieves minor aches and pains due to:

  • headache 
  • muscular aches 
  • backache 
  • minor pain of arthritis
  • common cold 
  • toothache 
  • premenstrual and menstrual cramps

WARNINGS SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (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

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

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. This Unit Dose package is not child

resistant and is Intended for Institutional Use Only.


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 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
  • children 6 years to under 12 yearstake 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do 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


INACTIVE INGREDIENT SECTION

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid.


SPL UNCLASSIFIED SECTION

Tamper Evident: Do not use if sealed blister units are broken or damaged.

Distributed By: MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152


HOW SUPPLIED

Product: 50090-4273

NDC: 50090-4273-0 1 TABLET in a BLISTER PACK / 30 in a BOX, UNIT-DOSE


Acetaminophen