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- Contains inactivated NDC Code(s)
NDC Code(s): 69512-190-10 - Packager: Alivio Medical Products, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 15, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- 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 (What is this?)
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.
See Alsoip190 500 OVAL WHITE Images - 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 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 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 tabletProduct 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 500mg in500mg 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)
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Safety
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NAPROXEN tablet
Number of versions: 1
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Oct 19, 2015 | 1 (current) | download |
RxNorm
NAPROXEN tablet
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 198014 | naproxen 500 MG Oral Tablet | PSN |
| 2 | 198014 | naproxen 500 MG Oral Tablet | SCD |
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NAPROXEN tablet
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NDC Codes
NAPROXEN tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 69512-190-10 (inactivated) |
