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Naproxen 500 mg Tablet, 60-count

by Proficient Rx LP · 60 TABLET in 1 BOTTLE (63187-455-60)

NDC 63187-0455-60

🏷️ FDA NDC (as labeled) 63187-455-60 billing pads the product segment with a zero

This package

Contains60-count Pack sizes4 compare ↓

Also priced by: Part D plans $0.1110/unit — full pricing hub ↓

Also comes in: 20 tablets 63187-0455-20 30 tablets 63187-0455-30 90 tablets 63187-0455-90

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Naproxen (different manufacturers) — 1 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Apr 20, 2026 — Chemical contamination; presence of lead and lithium above specification (Acella Pharmaceuticals, LLC) · FDA recall D-0523-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63187-455-60

Product NDC 63187-455

11-digit billing NDC 63187045560

NCPDP billing unit EA — each (per item)

RxCUI 198014

UNII 57Y76R9ATQ

Application # ANDA075927

SPL Set ID fc3ee94a-adb7-411e-a662-2f2c6ddbabaf

Established class (EPC) Nonsteroidal Anti-inflammatory Drug

Mechanism of action Cyclooxygenase Inhibitors

Chemical class Anti-Inflammatory Agents, Non-Steroidal

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2010-02-18

Route ORAL

Dosage form TABLET

Substance NAPROXEN

GPI-14 66100060000315

GPI class Naproxen

GCN Seq No 008362

GCN 35793

HICL code 003727

Ingredient (HICL) Naproxen

HIC1 code S

Therapeutic class — broad (HIC1) Locomotor System

HIC2 code S2

Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints

HIC3 code S2B

Therapeutic class — specific (HIC3) Nsaids, Cyclooxygenase Inhibitor Type Analgesics

AHFS code 28:08.04.04

AHFS class Reversible Cox-1/Cox-2 Inhibitors

FDB label name NAPROXEN 500 MG TABLET

FDB brand name Naproxen

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 63187-455-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0455-60. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug

Drug family (ATC) Propionic acid derivatives, Antiinflammatory products for vaginal administration, Antiinflammatory preparations, non-steroids for topical use

How it works Cyclooxygenase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP

Application holderAMNEAL PHARMACEUTICALS NY LLC

FDA applicationANDA075927 (ANDA)

Labeler code63187

First marketedFeb 2010

Product typeHuman Prescription Drug

Portfolio1,729 products on file

🔎 All NDCs from Proficient Rx LP

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NAPROXEN 500 MG TABLET Ingredient Naproxen

📗 Our plain-language guide HelloPharmacist

They're very similar — naproxen sodium is just the salt form of naproxen, and it dissolves in water more quickly. That means your body absorbs naproxen sodium a bit faster, so it t...
What's the difference between naproxen and naproxen sodium — are they the same thing?
You can take it either way, but taking it with food, milk, or a full glass of water is a good idea because it helps protect your stomach. Naproxen can irritate the lining of your s...
Can I take naproxen on an empty stomach, or do I need to eat first?

📖 Read our full Naproxen guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Naproxen — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Naproxen (311 interactions) — ranked by severity →

Nutrient depletion considerations

Naproxen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

FOLIC ACID Insufficient Evidence

🧪 Full Naproxen nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White

ShapeCapsule

ImprintIP190;500

Size16 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.1110	$6.66 / 60 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Naproxen 500 mg 49483-0618-01	TIME	100 tablets	$0.057	AB	Availability likely	—
Naproxen 500 mg 50228-0436-01	ScieGen	100 tablets	$0.057	AB	Availability likely	—
Naproxen 500 mg 60687-0491-01	American	100 tablets	$0.057	AB	Availability likely	—
Naproxen 500 mg 65162-0190-10	Amneal	100 tablets	$0.057	AB	Availability likely	—
Naproxen 500 mg 65862-0522-01	Aurobindo	100 tablets	$0.057	—	Availability likely	—
Naproxen 500 mg 68462-0190-01	Glenmark	100 tablets	$0.057	AB	Availability likely	—
Naproxen 500 mg 70010-0139-01	Granules	100 tablets	$0.057	AB	Availability likely	—
Naproxen 500 mg 76282-0342-01	Exelan	100 tablets	$0.057	—	Availability likely	—
Naproxen 500 mg 42494-0454-10	Cameron	100 tablets	$1.841	AB	Availability likely	—
Naproxen 500 mg 00615-8094-39	NCS	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 25000-0140-03	MARKSANS	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 42708-0043-20	QPharma,	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 42708-0140-20	QPharma	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 43063-0920-04	PD-Rx	4 tablets	—	AB	FDA listed	—
Naproxen 500 mg 43353-0211-53	Aphena	60 tablets	—	—	FDA listed	—
Naproxen 500 mg 50090-0481-00	A-S	15 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-0482-01	A-S	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-0483-00	A-S	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-5645-00	A-S	15 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-5646-01	A-S	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-5649-00	A-S	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-6666-00	A-S	15 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-6667-01	A-S	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-6762-00	A-S	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-6980-00	A-S	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-7198-00	A-S	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 50090-7676-00	A-S	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 51655-0363-26	Northwind	90 tablets	—	AB	FDA listed	—
Naproxen 500 mg 51655-0457-20	Northwind	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 51655-0621-20	Northwind	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 51655-0743-20	Northwind	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 53746-0190-01	Amneal	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 55700-0888-20	Quality	20 tablets	—	AB	Discontinued	—
Naproxen 500 mg 60760-0564-14	St.	14 tablets	—	AB	FDA listed	—
Naproxen 500 mg 62207-0747-43	Granules	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 63187-0028-10	Proficient	10 tablets	—	AB	FDA listed	—
Naproxen 500 mgthis 63187-0455-60	Proficient	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 63629-5863-01	Bryant	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 63629-8514-01	Bryant	500 tablets	—	AB	FDA listed	—
Naproxen 500 mg 63629-8515-01	Bryant	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 66267-0153-10	NuCare	10 tablets	—	AB	FDA listed	—
Naproxen 500 mg 66267-0807-04	NuCare	4 tablets	—	AB	FDA listed	—
Naproxen 500 mg 67046-0501-03	Coupler	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 67046-1553-03	Coupler	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 67296-2235-05	Redpharm	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 68071-2396-04	NuCare	4 tablets	—	AB	FDA listed	—
Naproxen 500 mg 68071-4006-01	NuCare	10 tablets	—	AB	FDA listed	—
Naproxen 500 mg 68071-4381-02	NuCare	20 tablets	—	AB	FDA listed	—
Naproxen 500 mg 68788-7090-01	Preferred	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 68788-8602-01	Preferred	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 68788-8797-01	Preferred	100 tablets	—	AB	FDA listed	—
naproxen 500 mg 69097-0855-07	Cipla	100 tablets	—	—	FDA listed	—
Naproxen 500 mg 70518-3822-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 70518-4439-00	REMEDYREPACK	12 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71205-0597-10	Proficient	10 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71335-0345-00	Bryant	28 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71335-2485-00	Bryant	28 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71335-2777-00	Bryant	28 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71610-0436-53	Aphena	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71610-0489-53	Aphena	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 71610-0597-53	Aphena	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 72189-0136-14	DIRECT	14 tablets	—	AB	FDA listed	—
Naproxen 500 mg 72789-0321-04	PD-Rx	4 tablets	—	AB	FDA listed	—
Naproxen 500 mg 72789-0541-14	PD-Rx	14 tablets	—	AB	FDA listed	—
Naproxen 500 mg 76420-0042-01	Asclemed	1 tablet	—	AB	FDA listed	—
Naproxen 500 mg 76420-0264-01	Asclemed	1 tablet	—	AB	FDA listed	—
Naproxen 500 mg 77771-0436-01	Radha	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 80425-0049-01	Advanced	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 80425-0050-01	Advanced	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 80425-0051-01	Advanced	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 80425-0378-01	Advanced	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 82461-0711-60	Medcore	60 tablets	—	AB	FDA listed	—
Naproxen 500 mg 83209-0190-14	Boswell	14 tablets	—	AB	FDA listed	—
Naproxen 500 mg 85509-1436-03	PHOENIX	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 85766-0107-00	Sportpharm	1000 tablets	—	AB	FDA listed	—
Naproxen 500 mg 72162-2276-01	Bryant	100 tablets	—	AB	FDA listed	—
Naproxen 500 mg 87441-0060-01	Unit	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 85534-0024-00	HAWAII	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 70518-1516-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Naproxen 500 mg 67046-0784-03	Coupler	30 tablets	—	AB	FDA listed	—
Naproxen 500 mg 70518-4750-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2010

On the market since

Feb 2010

📍

2026

Currently FDA-listed

16 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Naproxen — the program that covers self-administered drugs. 17 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Naproxen. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$5.99M

Claims incl. refills

655K

Beneficiaries

478.5K

Spend / beneficiary

$12.52

Spend / claim

$9.15

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Naproxen — the ingredient across all brands.

Top reported reactions

Pain13,409

Fatigue13,047

Nausea12,185

Arthralgia11,086

Headache10,504

Diarrhoea9,841

Dizziness9,098

Age at onset

Neonate147

Infant81

Child444

Adolescent528

Adult19,141

Elderly11,983

Reporter sex

Male · 32%

Female · 67%

Unknown · 0%

Serious outcomes

Hospitalization41,131

Disabling9,239

Life-threatening9,236

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
63187-0455-20	20 TABLET in 1 BOTTLE (63187-455-20)	2019-01-01	Active
63187-0455-30	30 TABLET in 1 BOTTLE (63187-455-30)	2019-01-01	Active
63187-0455-60 You're viewing this	60 TABLET in 1 BOTTLE (63187-455-60)	2019-01-01	Active
63187-0455-90	90 TABLET in 1 BOTTLE (63187-455-90)	2019-01-01	Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0455-60?

NDC 63187-0455-60 is a 60-count package — 60 tablet in 1 bottle.

What is the difference between NDC 63187-0455-60 and NDC 63187-0455-20?

Both are Naproxen 500 mg Tablet — the drug itself is identical. NDC 63187-0455-60 is the 60-count package, while NDC 63187-0455-20 is the 20 tablets package.

What NDC number is used to bill for this package of Naproxen 500 mg Tablet?

Bill NDC 63187-0455-60 — the 11-digit billing format is 63187045560. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 63187-455-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63187-0455-60, written without dashes as 63187045560. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 63187-0455-60, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0455) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 20 tablets (63187-0455-20), 30 tablets (63187-0455-30), 90 tablets (63187-0455-90). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide

🚨 Boxed Warning 128 words ▾

Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS ). • 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 cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ).

🎯 Indications and Usage 142 words ▾

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment options before deciding to use naproxen tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen, USP as naproxen tablets, USP is indicated: • For the relief of the signs and symptoms of rheumatoid arthritis • For the relief of the signs and symptoms of osteoarthritis • For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of juvenile arthritis • For relief of the signs and symptoms of tendonitis • For relief of the signs and symptoms of bursitis • For relief of the signs and symptoms of acute gout • For the management of pain • For the management of primary dysmenorrhea

⏱️ Dosage and Administration ~2 min read ▾

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. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with naproxen tablets, USP, the dose and frequency should be adjusted to suit an individual patient’s needs.

Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation. Although naproxen tablets, USP, naproxen suspension, naproxen delayed-release tablets, and naproxen sodium tablets all circulate in the plasma as naproxen, they have pharmacokinetic differences that may affect onset of action.

Onset of pain relief can begin within 1 hour in patients taking naproxen. The recommended strategy for initiating therapy is to choose a formulation and a starting dose likely to be effective for the patient and then adjust the dosage based on observation of benefit and/or adverse events. A lower dose should be considered in patients with renal or hepatic impairment or in elderly patients (see WARNINGS and PRECAUTIONS ).

Geriatric Patients Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose.

Patients With Moderate to Severe Renal Impairment Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) (see WARNINGS: Renal Effects ). Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis Naproxen Tablets, USP 250 mg or 375 mg or 500 mg twice daily twice daily twice daily During long-term administration, the dose of naproxen may be adjusted up or down depending on the clinical response of the patient. A lower daily dose may suffice for long-term administration.

The morning and evening doses do not have to be equal in size and the administration of the drug more frequently than twice daily is not necessary. In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/day for limited periods of up to 6 months when a higher level of anti-inflammatory/ analgesic activity is required. When treating such patients with naproxen 1500 mg/day, the physician should observe sufficient increased clinical benefits to offset the potential increased risk.

The morning and evening doses do not have to be equal in size and administration of the drug more frequently than twice daily does not generally make a difference in response (see CLINICAL PHARMACOLOGY ). Acute Gout The recommended starting dose is 750 mg of naproxen tablets, USP followed by 250 mg every 8 hours until the attack has subsided.

⛔ Contraindications 83 words ▾

CONTRAINDICATIONS Naproxen tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP. Naproxen tablets, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma ).

Naproxen tablets, USP are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

⚠️ Warnings ~3 min read ▾

WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective 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. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see WARNINGS: Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation ). Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS ).

Hypertension NSAIDs, including naproxen tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including naproxen tablets, should be used with caution in patients with hypertension.

Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Congestive Heart Failure and Edema Fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs. Naproxen tablets should be used with caution in patients with fluid retention, hypertension, or heart failure.

Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation NSAIDs, including naproxen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic.

Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only 1 in 5 patients who develop a serious GI adverse event on NSAID therapy is symptomatic. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.

Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debili…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg naproxen compared to those taking 750 mg naproxen (see CLINICAL PHARMACOLOGY ). In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with naproxen, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking naproxen in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Gastrointestinal (GI) Experiences, including: heartburn * , abdominal pain * , nausea * , constipation * , diarrhea, dyspepsia, stomatitis Central Nervous System: headache * , dizziness * , drowsiness * , lightheadedness, vertigo Dermatologic: pruritus (itching) * , skin eruptions * , ecchymoses * , sweating, purpura Special Senses: tinnitus * , visual disturbances, hearing disturbances Cardiovascular: edema * , palpitations.

General: dyspnea * , thirst * Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked. In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes The following are additional adverse experiences reported in <1% of patients taking naproxen during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized. Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever) Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema Gastrointestinal: inflammation, bleeding(sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper and lower gastrointestinal tract.

Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Chrohn’s disease). Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some cases have been fatal) Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia Metabolic and Nutritional: hyperglycemia, hypoglycemia Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions Respiratory: eosinophilic pneumonitis, asthma Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythemia multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa.

If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.…

🔄 Drug Interactions ~2 min read ▾

Drug Interactions Angiotensin Converting Enzyme (ACE)-inhibitors/Angiotensin Receptor Blockers (ARBs) NSAIDs may diminish the antihypertensive effect of ACE-inhibitors, ARBs, or beta-blockers (including propanolol). Monitor patients taking NSAIDs concomitantly with ACE-inhibitors, ARBs, or beta-blockers for changes in blood pressure. In addition, in patients who are elderly, volume-depleted (including those on diuretic therapy), or have compromised renal function, co-administration of NSAIDs with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure.

Monitor these patients closely for signs of worsening renal function. Antacids and Sucralfate Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. Aspirin When naproxen as naproxen tablets is administered with aspirin, its protein binding is reduced, although the clearance of free naproxen tablets is not altered.

The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects. Cholestyramine As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen. Diuretics Clinical studies, as well as postmarketing observations, have shown that naproxen tablets can reduce the natriuretic effect of furosemide and thiazides in some patients.

This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS: Renal Effects ), as well as to assure diuretic efficacy. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.

The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Naproxen and other nonsteroidal anti-inflammatory drugs have been reported to reduce the tubular secretion of methotrexate in an animal model. This may indicate that they could enhance the toxicity of methotrexate.

Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. No significant interactions have been observed in clinical studies with naproxen and coumarin-type anticoagulants.

However, caution is advised since interactions have been seen with other nonsteroidal agents of this class. The free fraction of warfarin may increase substantially in some subjects and naproxen interferes with platelet function. Selective Serotonin Reuptake Inhibitors (SSRIs) There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs.

Caution should be used when NSAIDs are administered concomitantly with SSRIs. Other Information Concerning Drug Interactions Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.

Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. Drug/Laborato…

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies have been performed in rats at 20 mg/kg/day (125 mg/m 2 /day, 0.23 times the human systemic exposure), rabbits at 20 mg/kg/day (220 mg/m 2 /day, 0.27 times the human systemic exposure), and mice at 170 mg/kg/day (510 mg/m 2 /day, 0.28 times the human systemic exposure) with no evidence of impaired fertility or harm to the fetus due to the drug. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.

Naproxen tablets should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus and intracranial hemorrhage. Naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction and abnormal prostaglandin E levels in preterm infants.

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. Naproxen-containing products are not recommended in labor and delivery because, through its prostaglandin synthesis inhibitory effect, naproxen may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.

The effects of naproxen tablets on labor and delivery in pregnant women are unknown.

🧒 Pediatric Use 18 words ▾

Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

🆘 Overdosage 158 words ▾

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. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare.

Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Treatment Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes.

Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. Pharmacokinetics Naproxen is rapidly and completely absorbed from the gastrointestinal tract with an in vivo bioavailability of 95%.

The different dosage forms of naproxen are bioequivalent in terms of extent of absorption (AUC) and peak concentration (C max ); however, the products do differ in their pattern of absorption. These differences between naproxen products are related to both the chemical form of naproxen used and its formulation. Even with the observed differences in pattern of absorption, the elimination half-life of naproxen is unchanged across products ranging from 12 to 17 hours.

Steady-state levels of naproxen are reached in 4 to 5 days, and the degree of naproxen accumulation is consistent with this half-life. This suggests that the differences in pattern of release play only a negligible role in the attainment of steady-state plasma levels. Absorption Immediate Release After administration of Naproxen Tablets, peak plasma levels are attained in 2 to 4 hours.

Distribution Naproxen has a volume of distribution of

0.16L/kg. At therapeutic levels naproxen is greater than 99% albumin-bound. At doses of naproxen greater than 500 mg/day there is less than proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses (average trough C ss 36.5, 49.2, and 56.4 mg/L with 500, 1000 and 1500 mg daily doses of naproxen, respectively).

The naproxen anion has been found in milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma (see PRECAUTIONS: Nursing Mothers ). Metabolism Naproxen is extensively metabolized in the liver to 6-0-desmethyl naproxen, and both parent and metabolites do not induce metabolizing enzymes. Both naproxen and 6-0-desmethyl naproxen are further metabolized to their respective acylglucuronide conjugated metabolites.

Excretion The clearance of naproxen is 0.13 mL/min/kg. Approximately 95% of the naproxen from any dose is excreted in the urine, primarily as naproxen (<1%), 6-0-desmethyl naproxen (<1%) or their conjugates (66% to 92%). The plasma half-life of the naproxen anion in humans ranges from 12 to 17 hours.

The corresponding half-lives of both naproxen’s metabolites and conjugates are shorter than 12 hours, and their rates of excretion have been found to coincide closely with the rate of naproxen disappearance from the plasma. Small amounts, 3% or less of the administered dose, are excreted in the feces. In patients with renal failure metabolites may accumulate (see WARNINGS: Renal Effects ).

Special Populations Geriatric Patients Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly, although the unbound fraction is < 1% of the total naproxen concentration. Unbound trough naproxen concentrations in elderly subjects have been reported to range from 0.12% to 0.19% of total naproxen concentration, compared with 0.05% to 0.075% in younger subjects. The clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients.

Race Pharmacokinetic differences due to race have not been studied. Hepatic Insufficiency Naproxen pharmacokinetics has not been determined in subjects with hepatic insufficiency. Renal Insufficiency Naproxen pharmacokinetics has not been determined in subjects with renal insufficiency.

Given that naproxen, its metabolites and conjugates are primarily excreted by the kidney, the potential exists…

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED Naproxen Tablets, USP, 500 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 190” on obverse and “500” on the reverse. They are available as follows: Bottles of 20: NDC 63187-455-20 Bottles of 30: NDC 63187-455-30 Bottles of 60: NDC 63187-455-60 Bottles of 90: NDC 63187-455-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev.

04-2013 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

📋 Description 140 words ▾

DESCRIPTION Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has the following structure: Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14 H 14 O 3 .

Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8.

Naproxen, USP is available as white tablets containing 250 mg of naproxen, USP, white tablets containing 375 mg of naproxen, USP and white tablets containing 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate. Formula Structure

💬 Medication Guide ~3 min read ▾

Medication Guide Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of NSAIDs • with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.

You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: • anytime during use • without warning symptoms • that may cause death The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs” • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • for the shortest time needed What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery.

Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems • have high blood pressure • have asthma • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. • are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” • new or worse high blood pressure • heart failure • liver problems including liver failure • kidney problems including kidney failure • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you get any of the following symptoms: • shortness of breath or trouble breathing • slurred speech • chest pain • swelling of the face or throat • weakness in one part or side of your body Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: • nausea • vomit blood • more tired or weaker than usual • there is blood in your bowel movement or it is black and sticky like tar • diarrhea • unusual weight gain • itching • skin rash or blisters with fever • your skin or eyes look yellow • swelling of the arms, legs, hands and feet • indigestion or stomach pain • flu-like symptoms If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

in vivo: In a living person or animal rather than in a laboratory dish.

synergistic: When two things taken together produce a larger effect than adding their separate effects would predict.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

alopecia: Loss of hair from the scalp or body.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

apnea: A pause or temporary stop in breathing.

aseptic meningitis: Swelling of the membranes around the brain and spinal cord that is not caused by common bacteria.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

depression: A lasting low mood with loss of interest that affects everyday life.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematemesis: Vomiting blood, which may look bright red or like dark coffee grounds.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lethargy: A state of tiredness and sluggishness, often with slowed thinking or movement.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

melena: Black, sticky, tar-like stools caused by blood that has been digested higher up in the gut.

metabolic acidosis: A condition where too much acid builds up in the body's blood and fluids.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photosensitivity: An unusually strong skin reaction, such as burning or rash, after being in sunlight or other ultraviolet light.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

pneumonitis: Inflammation of the lung tissue that is not caused by an infection and can lead to cough and breathlessness.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

pruritus: Itching of the skin.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

pulmonary hypertension: High blood pressure in the arteries that carry blood from the heart to the lungs.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

pyrexia: A raised body temperature; a fever.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

respiratory depression: Breathing that becomes too slow or too shallow to move enough air, so the body may not get enough oxygen.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trough: The lowest level a medicine reaches in the blood, just before the next dose is due.

ulceration: The forming of an open sore on the skin or on a lining inside the body, such as the stomach.

urticaria: Raised, itchy welts on the skin, commonly called hives.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 63187-0453-30 · Proficient 63187-0456-90 · Proficient →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Naproxen 500 mg Tablet, 60-count

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