Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 36d77c8e-a575-4cb3-9eb1-57c2ac384a5c
Route
ORAL
Published
Effective Date 2012-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Povidone Sodium Starch Glycolate Type A Potato Stearic Acid Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: GPI;A325 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-04-21
Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

for the temporary relief of 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.

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Purposes

Pain reliever/fever reducer

Warnings

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

  • 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 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

  • 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.

Directions
Do not take more than directed
  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.


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

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

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

Other Information
  • Store at room temperature

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

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.

Active Ingredients (in Each Tablet)

Acetaminophen 325 mg

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

 



Principal Display Panel  Tablets 325mg

 

Mapap 325mg tablet

Ask A Doctor Or Pharmacist Before Use If the User Is

taking the blood thinning drug warfarin

Structured Label Content

Uses

for the temporary relief of 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/fever reducer

Warnings

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

  • 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 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

  • 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.

Directions
Do not take more than directed
  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.


Do Not Use (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

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

Overdose Warning (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

Other Information (Other information)
  • Store at room temperature

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Stop Use and Ask A Doctor If (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.

Active Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

Acetaminophen 325 mg

Ask A Doctor Before Use If the User Has (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

 



Principal Display Panel  Tablets 325mg

 

Mapap 325mg tablet

Ask A Doctor Or Pharmacist Before Use If the User Is (Ask a doctor or pharmacist before use if the user is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:24.224528 · Updated: 2026-03-14T22:54:50.171645