Naproxen by Alivio Medical Products, LLC NAPROXEN tablet

Naproxen by

Drug Labeling and Warnings

Naproxen by is a Prescription medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Each capsule contains:

Naxproxen, ESP ..........500 mg

DESCRIPTION

Dosage and Use: For dosage recommendations

and other important prescribing information, read accompanying insert.

STORAGE AND HANDLING

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

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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

DESCRIPTION

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

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY

Pharmacodynamics - Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and

antipyretic properties.

CLINICAL STUDIES

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 & USAGE

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

CONTRAINDICATIONS

Naproxen tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP.

WARNINGS

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

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

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis

or osteoarthritis are listed below.

OVERDOSAGE

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 & ADMINISTRATION

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.

PATIENT MEDICATION INFORMATION

MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)

(See the end  of this Medication Guide for a list of prescription NSAID medicines.)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAPROXEN 
naproxen tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69512-190
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN	500 mg  in 500 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONES (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (White)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	IP190;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69512-190-10	100 in 1 BOTTLE
1		500 mg in 1 CAPSULE; Type 0: Not a Combination Product

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)