Acetaminophen 325mg

Manufacturer: Pharmaceutica North America, Inc. | Pure Source, LLC
Effective date: 2025-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: monthly-update
Hydrated at: 2026-06-03 17:46:45

Label at a glance#

ProductAcetaminophen 325mg

Active ingredientACETAMINOPHEN

Label structure8 sections

Indications and uses

• temporarily relieves 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

Dosage and administration

do not take more than directed (see overdose warning) adults and children 12 years and over take a 2 tablets, every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless direact by a doctor do not use more than 10 days unless directed by a doctor children 6 to under 12 years take a one tablet, every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do n...

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active Ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves 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

Warnings

WARNINGS SECTION

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.

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 istaking the blood thinning drug warfarin
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.
Overdose warning:
In the 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

DOSAGE & ADMINISTRATION SECTION

do not take more than directed (see overdose warning)


adults and children 12 years and over	take a 2 tablets, every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless direact by a doctor do not use more than 10 days unless directed by a doctor
children 6 to under 12 years	take a one tablet, every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use more than 5 days unless directed by a doctor
children under 6 years	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

• store between 20-25°C (68-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45861-085-01	EA - Each	45861-085	f49c11d6-07b8-480f-abac-d6a41534be3e	1	2025-05-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Acetaminophen 325mg
ACETAMINOPHEN
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
45861-085	45861-085-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
471bf791-410b-83e2-e063-6394a90aa959			9799e1a7-7402-457c-91fd-3db76bedf87a	2025-12-29	Warnings	Exact identifier spl id: 471bf791-410b-83e2-e063-6394a90aa959 spl set id: 9799e1a7-7402-457c-91fd-3db76bedf87a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.