drug facts

drug facts

SPL v16

SPL

SPL Set ID 4181efc2-d183-410c-b647-233444c57e32

Route

oral

Published

Effective Date 2024-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

acetaminophen (325 mg)

Inactive Ingredients

povidone starch, corn sodium starch glycolate type a corn stearic acid

Identifiers & Packaging

Pill Appearance

Imprint: PH020 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

otc monograph drug active Since 2007-01-09

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325mg

Medication Information

Warnings

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

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

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.

Active Ingredient

Acetaminophen 325mg

Uses

temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and 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 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directe by a doctor do not use for more than 10 days unless directed by a doctor
children 6 to under 12 years	take 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

Tamper Evident: do not use if seal is broken or missing from bottle.
store between 20-25°C (68-77°F)

Inactive Ingredients

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

Description

Acetaminophen 325mg

Questions?

Adverse drug event call:(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Section 51945-4

Acetaminophen 325mg each

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

Overdose Warning:

In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 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 the Reach of Children.

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

Warnings

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

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

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.

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 325mg

Uses

temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and 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 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directe by a doctor do not use for more than 10 days unless directed by a doctor
children 6 to under 12 years	take 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 (Other information)

Tamper Evident: do not use if seal is broken or missing from bottle.
store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

Questions?

Adverse drug event call:(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Section 51945-4 (51945-4)

Acetaminophen 325mg each

Do Not Use (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

Overdose Warning: (Overdose warning:)

In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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
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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

[{"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "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: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever", "51945-4": "Acetaminophen 325mg each", "Purpose": "Pain reliever/fever reducer", "Warnings": "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 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 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.", "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 directe by a doctor do not use for more than 10 days unless directed by a doctor children 6 to under 12 years take 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", "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", "Questions?": "Adverse drug event call: (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)", "Other information": "Tamper Evident: do not use if seal is broken or missing from bottle. store between 20-25°C (68-77°F)", "Overdose warning:": "In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "Inactive ingredients": "povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid", "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 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.", "Active ingredient (in each tablet)": "Acetaminophen 325mg", "Ask a doctor before use if you have": "liver disease", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:45.583474 · Updated: 2026-03-14T23:08:02.764471