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  • Manufacturer Name : Amneal
  • MFG # : 53746019405
  • NDC : 53746019405
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description N
Description -
Description N
DESI Drug Ind $1.01; 04/01/2017
DESI Drug Ind -
DESI Drug Ind $1.01; 04/01/2017
DESI2 Drug Ind AB
Drug Category NJ
Drug Category USES: See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Drug Category USES: See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Drug Type Code COMMON BRAND NAME(S): Aleve, Anaprox, Naprosyn
Drug Type Code COMMON BRAND NAME(S): Aleve, Anaprox, Naprosyn
Drug Type Code N
FDA Approval Date 08/03/2007
FDA Therap Equiv TAB
HCPCS -
HCPCS 1
HCPCS 1
Market Entry Date -
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (nah-PROX-en)
Termination Date (nah-PROX-en)
Termination Date 1
Unit 500
Units Per Pkg 04/26/2007
Active Ingredients 2381 naproxen sodium 26159342
Active Ingredients 2381 naproxen sodium 26159342
Active Ingredients 2381 naproxen sodium 26159342
AHFS Class 28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS; 92160000 ANTIGOUT AGENTS
AHFS Class 28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS; 92160000 ANTIGOUT AGENTS
AHFS Class 28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS; 92160000 ANTIGOUT AGENTS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 8358 naproxen sodium ORAL TABLET 550 MG
Gen Code and Des 8358 naproxen sodium ORAL TABLET 550 MG
Gen Code and Des 8358 naproxen sodium ORAL TABLET 550 MG
Inactive Ingredients 10138 blue dye; 2537 povidone 9003398
Inactive Ingredients 10138 blue dye; 2537 povidone 9003398
Inactive Ingredients 10138 blue dye; 2537 povidone 9003398
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 550MG
Strength 550MG
Strength 550MG
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Aleve, Anaprox, Naprosyn
Common Brand Name -
Drug Interaction -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (such as prednisone), lithium, "water pills" (diuretics such as furosemide). This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to naproxen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of naproxen may decrease aspirin's ability to prevent heart attack/stroke. Talk with your doctor about the risks and benefits. Ask about other medications that can be used to treat pain/fever. This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 500
Drug Form Pack Size 500
Drug Form Pack Size 500
Form TABLET
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 500
Unit Size 500
Unit Size 500
How to Use -
How to Use HOW TO USE: If you are taking the over-the-counter product, read all directions on the product package before taking this medication. If your doctor has prescribed this medication, read the Medication Guide provided by your pharmacist before you start taking naproxen and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually 2 or 3 times a day with a full glass of water (8 ounces/240 milliliters). Do not lie down for at least 10 minutes after taking this drug. To prevent stomach upset, take this medication with food, milk, or an antacid. The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed by your doctor or the package label. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor. For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit. If you are taking this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away. If you are using the nonprescription product to treat fever, consult the doctor right away if the fever worsens or lasts more than 3 days.
How to Use -
Missed Dose 500
Missed Dose 500
Missed Dose MISSED DOSE: If you are taking this drug on a regular schedule (not just "as needed") and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. If you have arthritis, lifestyle changes (such as weight loss if needed, strengthening/conditioning exercises) may help improve your flexibility and joint function. Consult your doctor for specific instructions.
Notes TAB
Notes TAB
Overdose AB
Overdose AB
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, extreme drowsiness, seizures.
Phonetic Pronunciation -
Phonetic Pronunciation -
Phonetic Pronunciation (nah-PROX-en)
Precautions -
Precautions -
Precautions PRECAUTIONS: Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), blood disorders (such as anemia), bleeding/clotting problems, growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, swelling (edema, fluid retention), stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers). Kidney problems can sometimes occur with the use of NSAID medications, including naproxen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis). This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Some naproxen products contain salt (sodium). Tell your doctor if you are on a salt-restricted diet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug. Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Side Effects -
Side Effects -
Side Effects SIDE EFFECTS: See also Warning section. Upset stomach, nausea, heartburn, headache, drowsiness, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, difficult/painful swallowing, hearing changes (such as ringing in the ears), mental/mood changes, signs of kidney problems (such as change in the amount of urine), unexplained stiff neck, vision changes, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage 04/26/2007
Storage 04/26/2007
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses -
Uses -
Uses USES: See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

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