Adwe Feverx Acetaminophen Caplets, 500 Mg Tablet
FDA Label NDC 71009-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurex Laboratories Limited Liability Company for the product Adwe Feverx Acetaminophen Caplets, 500 Mg (NDC 71009-109). 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 otc - active ingredient, otc - purpose, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Acetaminophen 500 mg

Otc - Purpose

Uses:

  • temporarily relives minor aches and pains
  • temporarily reduces fever

Warnings

Liver warninig: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets in 24 hours. Severe liver damage may occur if you take:

  • more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 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.

Otc - Ask Doctor

Ask a doctor before use if you have liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Dosage & Administration

Directions:

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed. Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
  • children under 12 years: ask a doctor

Storage And Handling

Other information

  • Store at 20° C - 25° C (68° F - 77° F)

Inactive Ingredient

Inactive ingredients:

microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.

How Supplied

* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

Distributed By:

Adwe Laboratories

1274 49 St. Brooklyn, NY 11219

This product contains no animal, soybean, or grain derivatives.

This product does not contain any Chometx or Krtnius.

REV 0221

* Please review the disclaimer below.