Naproxen Sodium Tablets, USP, Rx only, These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS., NAPROXEN SODIUM tablets, for oral use, Initial U.S. Approval: 1976

BOXED WARNING SECTION

id: 638a4320-9c21-4122-e053-2991aa0af758
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

FULL PRESCRIBING INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)]. • Naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), Warnings and Precautions (5.1)]. Gastrointestinal Bleeding, Ulceration, and Perforation • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)].

1 INDICATIONS AND USAGE

id: 637957d5-3e86-9f7a-e053-2a91aa0a4157
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Naproxen sodium tablets are indicated for:

the relief of the signs and symptoms of:

• rheumatoid arthritis

• osteoarthritis

• ankylosing spondylitis

• Polyarticular Juvenile Idiopathic Arthritis Naproxen sodium tablets are also indicated for:

the relief of signs and symptoms of:

• tendonitis

• bursitis

• acute gout the management of:

• pain

• primary dysmenorrhea

3 DOSAGE FORMS AND STRENGTHS

id: 63737fdd-40ab-c3bc-e053-2991aa0a9ccb
displayName: DOSAGE FORMS & STRENGTHS SECTION
FDA Article Code: 43678-2

Naproxen Sodium Tablets, USP 275 mg, blue, oval, biconvex, film coated tablets debossed “IP193” on obverse and plain on reverse. Naproxen Sodium Tablets, USP 550 mg, are supplied as blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse.

4 CONTRAINDICATIONS

id: 637333e4-638c-371d-e053-2a91aa0a707b
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Naproxen sodium is contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product
[see Warnings and Precautions (5.7, 5.9)]

• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
[see Warnings and Precautions (5.7, 5.8)]

• In the setting of coronary artery bypass graft (CABG) surgery
[see Warnings and Precautions (5.1)]

6 ADVERSE REACTIONS

id: 63741c04-f5b1-d8ad-e053-2991aa0a2e08
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events
[see Warnings and Precautions (5.1)]

• GI Bleeding, Ulceration, and Perforation
[see Warnings and Precautions (5.2)]

• Hepatotoxicity
[see Warnings and Precautions (5.3)]

• Hypertension
[see Warnings and Precautions (5.4)]

• Heart Failure and Edema
[see Warnings and Precautions (5.5)]

• Renal Toxicity and Hyperkalemia
[see Warnings and Precautions (5.6)]

• Anaphylactic Reactions
[see Warnings and Precautions (5.7)]

• Serious Skin Reactions
[see Warnings and Precautions (5.9)]

• Hematologic Toxicity
[see Warnings and Precautions (5.11)]

7 DRUG INTERACTIONS

id: 638a6376-8e2b-7fbc-e053-2a91aa0a20b9
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7

See Table 2 for clinically significant drug interactions with naproxen. • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.

Table 2: Clinically Significant Drug Interactions with naproxen

Drugs That Interfere with Hemostasis
Clinical Impact:	• Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention:	Monitor patients with concomitant use of naproxen sodium with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.11)].
Aspirin
Clinical Impact:	Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.2)].
Intervention:	Concomitant use of naproxen sodium and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.11)]. naproxen sodium are not substitutes for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:	• NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:	• During concomitant use of naproxen sodium and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. • During concomitant use of naproxen sodium and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions (5.6)]. • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact:	Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of naproxen sodium with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions (5.6)].
Digoxin
Clinical Impact:	The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin
Intervention:	During concomitant use of naproxen sodium and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact:	NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of naproxen sodium and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact:	Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:	During concomitant use of naproxen sodium and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact:	Concomitant use of naproxen sodium and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention:	During concomitant use of naproxen sodium and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact:	Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.2)].
Intervention:	The concomitant use of naproxen with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact:	Concomitant use of naproxen sodium and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention:	During concomitant use of naproxen sodium and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
Antacids and Sucralfate
Clinical Impact:	Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.
Intervention:	Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen sodium is not recommended.
Cholestyramine
Clinical Impact:	Concomitant administration of cholestyramine can delay the absorption of naproxen.
Intervention:	Concomitant administration of cholestyramine with naproxen sodium is not recommended.
Probenecid
Clinical Impact:	Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
Intervention:	Patients simultaneously receiving naproxen sodium and probenecid should be observed for adjustment of dose if required.
Other albumin-bound drugs
Clinical Impact:	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.
Intervention:	Patients simultaneously receiving naproxen sodium and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.
Drug/Laboratory Test Interactions
Bleeding times
Clinical Impact:	Naproxen may decrease platelet aggregation and prolong bleeding time.
Intervention:	This effect should be kept in mind when bleeding times are determined.
Porter-Silber test
Clinical Impact:	The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay.
Intervention:	Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.
Urinary assays of 5-hydroxy indoleacetic acid (5HIAA)
Clinical Impact:	Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA)
Intervention:	This effect should be kept in mind when urinary 5-hydroxy indoleacetic acid is determined.

10 OVERDOSAGE

id: 6374e8ff-23c7-e471-e053-2a91aa0ab50b
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare
[see Warnings and Precautions (5.1, 5.2)].Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced convulsions, but it is not clear whether or not these were drug-related. It is not known what dose of the drug would be life threatening.
[see Warnings and Precautions (5.1, 5.2, 5.4, 5.6)]. Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).

11 DESCRIPTION

id: 6374e8ff-23d8-e471-e053-2a91aa0ab50b
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen sodium, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid, sodium salt. Naproxen sodium, USP has the following structures: Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen sodium, USP is available as blue tablets containing 275 mg of naproxen sodium, USP and as blue tablets containing 550 mg of naproxen sodium, USP for oral administration. The inactive ingredients are croscarmellose sodium, macrogol, magnesium stearate, polyvinyl alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.

14 CLINICAL STUDIES

id: 637544e2-f0f8-7547-e053-2991aa0a795c
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7

Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout. Improvement in patients treated for rheumatoid arthritis was demonstrated by a reduction in joint swelling, a reduction in duration of morning stiffness, a reduction in disease activity as assessed by both the investigator and patient, and by increased mobility as demonstrated by a reduction in walking time. Generally, response to naproxen has not been found to be dependent on age, sex, severity or duration of rheumatoid arthritis. In patients with osteoarthritis, the therapeutic action of naproxen has been shown by a reduction in joint pain or tenderness, an increase in range of motion in knee joints, increased mobility as demonstrated by a reduction in walking time, and improvement in capacity to perform activities of daily living impaired by the disease. In a clinical trial comparing standard formulations of naproxen 375 mg twice a day (750 mg a day) vs 750 mg twice a day (1,500 mg/day), 9 patients in the 750 mg group terminated prematurely because of adverse events. Nineteen patients in the 1,500 mg group terminated prematurely because of adverse events. Most of these adverse events were gastrointestinal events. In clinical studies in patients with rheumatoid arthritis, osteoarthritis, and polyarticular juvenile idiopathic arthritis, naproxen has been shown to be comparable to aspirin and indomethacin in controlling the aforementioned measures of disease activity, but the frequency and severity of the milder gastrointestinal adverse effects (nausea, dyspepsia, heartburn) and nervous system adverse effects (tinnitus, dizziness, lightheadedness) were less in naproxen-treated patients than in those treated with aspirin or indomethacin. In patients with ankylosing spondylitis, naproxen has been shown to decrease night pain, morning stiffness and pain at rest. In double-blind studies the drug was shown to be as effective as aspirin, but with fewer side effects. In patients with acute gout, a favorable response to naproxen was shown by significant clearing of inflammatory changes (e.g., decrease in swelling, heat) within 24 to 48 hours, as well as by relief of pain and tenderness. Naproxen has been studied in patients with mild to moderate pain secondary to postoperative, orthopedic, postpartum episiotomy and uterine contraction pain and dysmenorrhea. Onset of pain relief can begin within 1 hour in patients taking naproxen and within 30 minutes in patients taking naproxen sodium. Analgesic effect was shown by such measures as reduction of pain intensity scores, increase in pain relief scores, decrease in numbers of patients requiring additional analgesic medication, and delay in time to remedication. The analgesic effect has been found to last for up to 12 hours. Naproxen may be used safely in combination with gold salts and/or corticosteroids; however, in controlled clinical trials, when added to the regimen of patients receiving corticosteroids, it did not appear to cause greater improvement over that seen with corticosteroids alone. Whether naproxen has a “steroid-sparing” effect has not been adequately studied. When added to the regimen of patients receiving gold salts, naproxen did result in greater improvement. Its use in combination with salicylates is not recommended because there is evidence that aspirin increases the rate of excretion of naproxen and data are inadequate to demonstrate that naproxen and aspirin produce greater improvement over that achieved with aspirin alone. In addition, as with other NSAIDs, the combination may result in higher frequency of adverse events than demonstrated for either product alone. In
⁵¹Cr blood loss and gastroscopy studies with normal volunteers, daily administration of 1,000 mg of naproxen1,100 mg of naproxen sodium has been demonstrated to cause statistically significantly less gastric bleeding and erosion than 3,250 mg of aspirin.

16 HOW SUPPLIED/STORAGE AND HANDLING

id: 637544e2-f0f9-7547-e053-2991aa0a795c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Naproxen Sodium Tablets, USP
275 mg, are supplied as blue, oval, biconvex, film coated tablets debossed “IP193” on obverse and plain on reverse. They are available as follows: Bottle of 100 Tablets: NDC 42291-516-01 Naproxen Sodium Tablets, USP
550 mg, are supplied as blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse. They are available as follows: Bottle of 100 Tablets: NDC 42291-517-01

Bottle of 500 Tablets: NDC 42291-517-50 Store at 20° to 25°C (68° to 77°F); excursions permitted between 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.

17 PATIENT COUNSELING INFORMATION

id: 6375306a-66ee-4c08-e053-2991aa0a19f7
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with naproxen sodium and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately
[see Warnings and Precautions (5.1)]. Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding
[see Warnings and Precautions (5.2)]. Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop naproxen sodium and seek immediate medical therapy
[see Warnings and Precautions (5.3)]. Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur
[see Warnings and Precautions (5.5)]. Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur
[see Contraindications (4) and Warnings and Precautions (5.7)]. Serious Skin Reactions

Advise patients to stop naproxen sodium immediately if they develop any type of rash and to contact their healthcare provider as soon as possible
[see Warnings and Precautions (5.9)]. Female Fertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including naproxen sodium, may be associated with a reversible delay in ovulation
[see Use in Specific Populations (8.3]. Fetal Toxicity

Inform pregnant women to avoid use of naproxen sodium and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus
[see Warnings and Precautions (5.10) and Use in Specific Populations (8.1)]. Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of naproxen sodium with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy
[see Warnings and Precautions (5.2) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with naproxen sodium until they talk to their healthcare provider
[see Drug Interactions (7)]. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Mfg. Rev. 08-2017-03

AV 09/17 (P)

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

id: 63754cf1-2cf7-801a-e053-2991aa0a3e01
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1

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:

o with increasing doses of NSAIDs

o 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:

o anytime during use

o without warning symptoms

o that may cause death The risk of getting an ulcer or bleeding increases with:

o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”

o increasing doses of NSAIDs

o longer use of NSAIDs

o smoking

o drinking alcohol

o older age

o poor health

o advanced liver disease

o bleeding problems NSAIDs should only be used:

o exactly as prescribed

o at the lowest dose possible for your treatment

o 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 not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about NSAIDs

• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

• Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. General information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478 Rev. 08-2017-03

Mfg. 09/17 (P)