Naproxen

NAPROXEN- naproxen tablet
Alivio Medical Products, LLC

Each capsule contains:

Naxproxen, ESP ……….500 mg

Dosage and Use: For dosage recommendations

and other important prescribing information, read accompanying insert.

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.

DESCRIPTION

Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.

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
(click image for full-size original)

NAPROXEN
naproxen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 500 mg in 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
POVIDONES
MAGNESIUM STEARATE
Product Characteristics
Color white (White) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code IP190;500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69512-190-10 100 CAPSULE in 1 BOTTLE contains a CAPSULE
1 500 mg in 1 CAPSULE This package is contained within the BOTTLE (69512-190-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075927 10/01/2015
Labeler — Alivio Medical Products, LLC (079670828)

Revised: 10/2015 Alivio Medical Products, LLC

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