Acetaminophen Usp 325 Mg Tablets

SPL v3

SPL

SPL Set ID c7ea2bfc-d0f0-4f49-9fc0-00bddc6886ca

Route

ORAL

Published

Effective Date 2023-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg)

Inactive Ingredients

Starch, Corn Sodium Starch Glycolate Type A Potato Stearic Acid Povidone, Unspecified

Identifiers & Packaging

Pill Appearance

Imprint: AP;012 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2015-11-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer

How Supplied

Product: 50090-5459 NDC: 50090-5459-4 20 TABLET in a BOTTLE

Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

Product: 50090-5459

NDC: 50090-5459-4 20 TABLET in a BOTTLE

Description

Drug Facts

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual or menstrual cramps

temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children
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.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if the user has liver disease

Section 50570-1

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.

Section 53414-9

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

Section 60561-8

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

skin reddening
blisters
rash

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

Warnings

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

adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
child takes more than 5 tablets in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks while using this product

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years	take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years	do not use

Other Information

store at 15° to 30°C (59° to 86°F)

Inactive Ingredients

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Tablet)

Acetaminophen USP, 325 mg

Acetaminophen 325 Mg (acetaminophen) Tablet

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual or menstrual cramps

temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children
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.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver disease

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

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

skin reddening
blisters
rash

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

Purpose

Pain reliever/fever reducer

Warnings

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

adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
child takes more than 5 tablets in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks while using this product

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years	take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 years	do not use

How Supplied (HOW SUPPLIED)

Product: 50090-5459

NDC: 50090-5459-4 20 TABLET in a BOTTLE

Other Information (Other information)

store at 15° to 30°C (59° to 86°F)

Inactive Ingredients (Inactive ingredients)

povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen USP, 325 mg

Acetaminophen 325 Mg (acetaminophen) Tablet (ACETAMINOPHEN 325 MG (ACETAMINOPHEN) TABLET)

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual or menstrual cramps temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "50566-9": "Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children 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.", "50568-5": "Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if the user has liver disease", "50570-1": "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "60561-8": "Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount child takes more than 5 tablets in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks while using this product", "Directions": "do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours children 6 to 11 years take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours children under 6 years do not use", "HOW SUPPLIED": "Product: 50090-5459 NDC: 50090-5459-4 20 TABLET in a BOTTLE", "Other information": "store at 15° to 30°C (59° to 86°F)", "Inactive ingredients": "povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid", "Questions or comments?": "call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday", "Active ingredient (in each tablet)": "Acetaminophen USP, 325 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:31.866724 · Updated: 2026-03-14T23:01:00.090870