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Ibuprofen 600Mg Tab 100

  • Manufacturer Name : ASCEND LABORATO
  • MFG # : 67877032001
  • NDC : 67877032001
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
327072 UN
$7.02
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Additional Information

Product NameIbuprofen 600 Mg Tab 100
ApplicationNonsteroidal Anti-Inflammatory Drug (NSAID)
Generic Drug NameIbuprofen
Mechanism of ActionInhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis to relieve pain, inflammation, and fever
Strength600 mg
Dosage FormTablet
TypeOral
Onset of ActionWithin 30-60 minutes
Duration of Action6-8 hours
Elimination RouteHepatic metabolism, renal excretion
Adverse EffectsNausea, dyspepsia, headache, dizziness, gastrointestinal bleeding, hypertension, fluid retention
Pregnancy CategoryC (first and second trimester), D (third trimester)
PackagingBottle of 100 tablets
IndicationsOsteoarthritis, rheumatoid arthritis, dysmenorrhea, musculoskeletal pain, fever, postoperative pain

Description

Ibuprofen 600 mg tablets are nonsteroidal anti-inflammatory drugs (NSAIDs) used to manage mild to moderate pain, inflammation, and fever. They inhibit cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis, which is responsible for inflammation and pain. The drug is indicated for conditions such as osteoarthritis, rheumatoid arthritis, dysmenorrhea, and musculoskeletal disorders. It is also used postoperatively and for dental pain.

Each tablet contains 600 mg of ibuprofen formulated for oral administration. The drug is rapidly absorbed in the gastrointestinal tract, reaching peak plasma concentrations within one to two hours. Food intake may delay absorption but does not significantly affect overall bioavailability. The analgesic and anti-inflammatory effects are dose-dependent, with a typical dosing interval of every six to eight hours as needed.

Adverse effects include gastrointestinal irritation, nausea, dyspepsia, headache, dizziness, and fluid retention. Long-term use or high doses may increase the risk of gastrointestinal ulcers, bleeding, and cardiovascular events such as myocardial infarction and stroke. Caution is required in patients with a history of gastrointestinal disorders, cardiovascular disease, renal impairment, or hypertension.

Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 1
FDA Approval Date 09/15/2015
FDA Therap Equiv AB
HCPCS -
Market Entry Date 05/24/2016
Medical Coverage -
Termination Date -
Unit TAB
Units Per Pkg 1
Active Ingredients 2377 ibuprofen 15687271
AHFS Class 28080492 OTHER NONSTEROIDAL ANTI-INFLAM. AGENTS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 8349 ibuprofen ORAL TABLET 600 MG
Inactive Ingredients 2537 povidone 9003398
OMP Family -
Product Category RX Pharmaceuticals
Strength 600MG
Common Brand Name COMMON BRAND NAME(S): Advil, Motrin, Nuprin
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 include: 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 (including aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must take ibuprofen, talk to your doctor about taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take ibuprofen at least 8 hours before or at least 2 hours after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.
Allocation Period -
Case Quantity 24
Drug Form Pack Size 100
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 100
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 ibuprofen and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth, usually every 4 to 6 hours with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. If you have stomach upset while taking this medication, take it 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. When ibuprofen is used by children, the dose is based on the child's weight. Read the package directions to find the proper dose for your child's weight. Consult the pharmacist or doctor if you have questions or if you need help choosing a nonprescription product. 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 yourself or a child for fever or pain, consult the doctor right away if fever gets worse or lasts more than 3 days, or if pain worsens or lasts more than 10 days.
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: If your doctor has prescribed this medication, do not share it with others. Lab and/or medical tests (such as blood pressure, kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
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, trouble breathing, extreme drowsiness.
Phonetic Pronunciation (eye-byou-PRO-fen)
Precautions PRECAUTIONS: Before taking ibuprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as naproxen, 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing 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, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers). Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. 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. Limit alcoholic beverages. 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. Consult your doctor or pharmacist for more information. 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. 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 medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Upset stomach, nausea, vomiting, headache, diarrhea, constipation, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. If your doctor has prescribed 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, hearing changes (such as ringing in the ears), mental/mood changes, unexplained stiff neck, signs of kidney problems (such as change in the amount of urine), 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, dark urine, stomach/abdominal pain, yellowing eyes/skin. 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 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: Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever. 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. See also Warning section. 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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Ibuprofen 600Mg Tab 100 is manufactured by ASCEND LABORATO.
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