The following Structured Product Label (SPL) was submitted to the FDA by Alivio Medical Products, Llc for the product Naproxen (NDC 69512-190). 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 description, storage and handling, boxed warning, clinical pharmacology, clinical studies, indications & usage, contraindications, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Each capsule contains:
Naxproxen, ESP ..........500 mg
Dosage and Use: For dosage recommendations
and other important prescribing information, read accompanying insert.
DESCRIPTION
Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.
Store at 20 to 25 C (68 to 77 F); excursions
permitted to 15 to 30 C (59 to 86 F)[See
USP Controlled Room Temperature]
Dispense in well-closed, light-resistant containers
as defined in the USP.
BOXED WARNING
Cardiovascular Risk
-NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal.
-Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri-operative
pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
-NSAIDs may cause an increased risk of serious gastrointestinal adverse events including
bleeding, ulceration. and perforation of the stomach or intestines, which can be fatal.
CLINICAL PHARMACOLOGY
Pharmacodynamics - Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and
antipyretic properties.
CLINICAL STUDIES
General Information - Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis,
juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout.
INDICATIONS AND USAGE
Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatments
before deciding to sue naproxen tablets, USP.
CONTRAINDICATIONS
Naproxen tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP.
WARNINGS
Cardiovascular Effects - Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective
and non-selective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV)
thrombotic events, myocardial infarction, and stroke, which can be fatal.
PRECAUTIONS
General - Naproxen - containing products such as naproxen tablets, and other naproxen products should
not be used concomitantly since they all circulate in the plasma as the naproxin anion.
ADVERSE REACTIONS
Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis
or osteoarthritis are listed below.
OVERDOSAGE
Symptoms and Signs Significant naproxen overdosage may be characterized by lethargy, dizziness,
drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function,
hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting.
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment
options before deciding to use naproxen tablets, USP.
MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
Copy Of Label (Naproxen Label)
* Please review the disclaimer below.
