Acetaminophen
FDA Label NDC 10135-152

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 (NDC 10135-152). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, 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)            

Acetaminophen USP 500 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 6 tablets (3,000 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.

Ask A Doctor Before Use If You Have

liver disease.

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.

Directions

Do not take more than directed (see overdose warning)

Adults and Children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.
  • Do not take more than 6 tablets in 24 hours, unless directed by a doctor.
  • Do not use for more than 10 days unless directed by a doctor.

    • Children under 12 years:

    • ask a doctor.

Other Information

  • Store between 20-25˚C (68-77˚F).
  • See end panel for lot number and expiration date.

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Distributed by:
Marlex Pharmaceuticals, Inc.
50 McCullough Drive
New Castle, DE 19720

Principal Display Panel

NDC 10135-152-01
ACETAMINOPHEN
500 MG

Principal Display Panelndc 10135-152-01acetaminophen500 mg (Acetaminophen 01)

Principal Display Panelndc 10135-152-01acetaminophen500 mg (Acetaminophen 01)

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