Acetaminophen 325mg
FDA Label NDC 10135-123

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Acetaminophen 325mg (NDC 10135-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor or pharmacist before use, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Ask A Doctor Or Pharmacist Before Use

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Overdose Warning:

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Acetaminophen USP 325 mg

Purpose

Pain Reliever/ Fever Reducer

Uses

Temporary 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.

Warnings

Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
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.

Drug Facts (continued)

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.

Stop Use And Ask A Doctor If

Pain gets worse or lasts more than 10 days.
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.

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.