acetaminophen usp 325 mg tablets

SPL v5

SPL

SPL Set ID 6794830a-7856-464d-84be-c8b253cf41ac

Route

oral

Published

Effective Date 2025-10-01

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 drug active Since 2015-11-01

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

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

Active Ingredient

Acetaminophen USP, 325 mg

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

Purpose

Pain reliever/fever reducer

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

Description

Drug Facts

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 51945-4

NDC 71205-456-30

Regular Strength

Acetaminophen USP 325 mg

PAIN RELIEVER

FEVER REDUCER

30 TABLETS

*Compare to Active Ingredient in Regular Strength TYLENOL®

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.

Questions Or Comments?

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

Structured Label Content

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

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen USP, 325 mg

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

Purpose

Pain reliever/fever reducer

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 (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

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 51945-4 (51945-4)

NDC 71205-456-30

Regular Strength

Acetaminophen USP 325 mg

PAIN RELIEVER

FEVER REDUCER

30 TABLETS

*Compare to Active Ingredient in Regular Strength TYLENOL®

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.

Questions Or Comments? (Questions or comments?)

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

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.", "51945-4": "NDC 71205-456-30 Regular Strength Acetaminophen USP 325 mg PAIN RELIEVER FEVER REDUCER 30 TABLETS *Compare to Active Ingredient in Regular Strength TYLENOL®", "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", "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: 2026-02-15T12:02:48.412531 · Updated: 2026-03-14T23:13:18.140905