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Drug Facts


Active Ingredients (in each tablet)

Acetaminophen 325 mg


Purposes

Pain reliever/fever reducer


Uses

for the temporary relief of minor aches and pains due to:

Temporarily reduces fever.

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

Do not use

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

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 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.

  • adult takes more than 12 tablets in 24 hours,which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • 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 non prescription). 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 warning: This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 12 tablets in 24 hours,which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen? adult has 3 or more alcoholic drinks every day while using this productDo not usewith 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 productAsk a doctor before use if the user has liver diseaseAsk a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.Stop use and ask a doctor if Pain gets worse or lasts more than 10 days in adults and children 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.? 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 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. with any other drug containing acetaminophen (prescription or non prescription). 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 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 and children
  • 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

Taking more than the recommended dose (overdose) may cause liver damage. 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.

Liver warning: This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 12 tablets in 24 hours,which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen? adult has 3 or more alcoholic drinks every day while using this productDo not usewith 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 productAsk a doctor before use if the user has liver diseaseAsk a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.Stop use and ask a doctor if Pain gets worse or lasts more than 10 days in adults and children 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.? These could be signs of a serious conditionIf 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 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.with any other drug containing acetaminophen (prescription or non prescription). 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


Directions

  AGE  DOSE
  Adults and children 12 years and over   Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours
  Children 6 to 11 years   Take 1 tablet every 4 to 6 hours while symptoms last  Do not take more than 5 tablets in 24 hours
  Children under 6 years  Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

  • Store at room temperature

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid


Questions?

To Report Adverse Drug Event call (800) 616-2471 Dist. By MAJOR PHARMACEUTICALS 31778 Enterprise Drive. Livonia, MI  48150

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

Reorder No. 251706