Ibuprofen 600mg Tablets

Manufacturer ASCEND Active Ingredient Ibuprofen Tablets(eye byoo PROE fen) Pronunciation eye-byoo-PROE-fen
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to ease pain, swelling, and fever.It is used to ease painful period (menstrual) cycles.It is used to treat arthritis.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID), Analgesic, Antipyretic
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Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
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Pregnancy Category
Category C (1st and 2nd trimester); Category D (3rd trimester)
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FDA Approved
May 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ibuprofen is a medicine used to relieve pain, reduce fever, and lessen inflammation (swelling and redness). It belongs to a group of medicines called NSAIDs. It works by blocking certain natural substances in your body that cause pain and inflammation.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. Always take it with a full glass of water.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Protect it from heat and keep it out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at once or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Drink a full glass of water with each dose.
  • Avoid alcohol while taking ibuprofen, as it can increase the risk of stomach bleeding.
  • Do not take more than the recommended dose or for longer than recommended without consulting a doctor.
  • Inform your doctor or dentist that you are taking ibuprofen before any surgery or dental procedures.
  • Avoid taking other NSAIDs (like naproxen, celecoxib, or aspirin for pain) concurrently without medical advice.

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg orally every 6-8 hours as needed for pain/inflammation
Dose Range: 400 - 800 mg

Condition-Specific Dosing:

mildToModeratePain: 400-600 mg orally every 4-6 hours as needed, Max 2400 mg/day
rheumatoidArthritisOsteoarthritis: 400-800 mg orally 3-4 times daily, Max 3200 mg/day (prescription strength)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for 600mg strength; lower strengths (e.g., 50-100mg/5mL suspension) are used for fever/pain based on weight.
Child: Not established for 600mg strength; typically 5-10 mg/kg/dose every 6-8 hours for fever/pain, max 40 mg/kg/day. 600mg is generally too high for most children.
Adolescent: For adolescents weighing >40 kg, adult dosing may be considered for specific indications, but 600mg is a high single dose. Max 2400 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Avoid use if possible; if necessary, use lowest effective dose for shortest duration. Monitor renal function closely.
Severe: Contraindicated due to risk of worsening renal function.
Dialysis: Ibuprofen is not significantly removed by hemodialysis. Avoid use due to risk of adverse effects.

Hepatic Impairment:

Mild: Use with caution; monitor liver function tests.
Moderate: Use with caution; consider dose reduction and monitor liver function tests closely.
Severe: Avoid use; no specific dosing recommendations, increased risk of adverse effects.

Pharmacology

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Mechanism of Action

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that exerts its therapeutic effects primarily by inhibiting the cyclooxygenase (COX) enzymes, COX-1 and COX-2. This inhibition leads to a reduction in the synthesis of prostaglandins, thromboxanes, and prostacyclins, which are mediators of inflammation, pain, and fever. Inhibition of COX-1 contributes to gastrointestinal and platelet-related side effects, while inhibition of COX-2 is primarily responsible for the anti-inflammatory, analgesic, and antipyretic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 1-2 hours (oral)
FoodEffect: Food may decrease the rate but not the extent of absorption, potentially delaying Tmax.

Distribution:

Vd: 0.1-0.2 L/kg
ProteinBinding: >99% (primarily to albumin)
CnssPenetration: Limited, but sufficient to exert central antipyretic effects.

Elimination:

HalfLife: 1.8-2.5 hours
Clearance: Not available (variable)
ExcretionRoute: Renal (approximately 60-90% as metabolites and their conjugates, 1% as unchanged drug)
Unchanged: Approximately 1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (analgesia)
PeakEffect: 1-2 hours (analgesia), 2-4 hours (anti-inflammatory)
DurationOfAction: 4-6 hours (analgesia), up to 8 hours (anti-inflammatory)

Safety & Warnings

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BLACK BOX WARNING

CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs may 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. Ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic reactions: Rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, fainting, numbness, tingling, or shortness of breath.
High blood pressure: Severe headache, dizziness, fainting, or changes in vision.
Respiratory issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular concerns: Chest pain, pressure, or rapid heartbeat.
Neurological symptoms: Weakness on one side of the body, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
General concerns: Extreme fatigue, weakness, ringing in the ears, severe back pain, or changes in vision.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek immediate medical help if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
* Dizziness

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools, or vomit that looks like coffee grounds (signs of stomach bleeding)
  • Chest pain, shortness of breath, sudden weakness or numbness on one side of the body, or slurred speech (signs of heart attack or stroke)
  • Sudden weight gain or swelling in your hands or feet (signs of fluid retention or heart problems)
  • Skin rash, hives, blistering, or peeling skin (signs of severe allergic reaction)
  • Yellowing of the skin or eyes, dark urine, or unusual tiredness (signs of liver problems)
  • Decreased urination or swelling in your legs (signs of kidney problems)
  • Unexplained fever, sore throat, or other signs of infection (may indicate blood dyscrasias)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate drugs (e.g., aspirin) or NSAIDs.
Certain health issues, including:
+ Gastrointestinal (GI) bleeding
+ Kidney problems
+ Heart failure (a weakened heart)
+ Recent heart attack
Concurrent use of other NSAIDs, salicylate drugs (e.g., aspirin), or pemetrexed.
Fertility issues or ongoing fertility evaluation, as this medication may affect fertility.
* Pregnancy, planned pregnancy, or suspected pregnancy. This medication can harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss any concerns or questions you have with your doctor.

Drugs similar to this one have been associated with an increased risk of high blood pressure. To minimize this risk, follow your doctor's instructions for monitoring your blood pressure.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions. If you smoke, talk to your doctor about the potential effects on your health. Additionally, if you have asthma, inform your doctor, as you may be more sensitive to this medication.

Adhere to the dosage instructions provided by your doctor, and do not exceed the recommended amount. Taking more than prescribed may increase your risk of severe side effects. Furthermore, do not take this medication for longer than your doctor has advised.

As this drug may affect your blood's ability to clot, you may be more prone to bleeding. To minimize this risk, be cautious and avoid injuries. Use a soft toothbrush and an electric razor to reduce the risk of bleeding.

The use of drugs like this one has been linked to an increased risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these risks with your doctor.

In people who have recently experienced a heart attack, the use of drugs like this one may increase the risk of another heart attack and heart-related death. Additionally, research has shown that people taking drugs like this one after a first heart attack were more likely to die in the following year compared to those not taking these medications. It is crucial to discuss these risks with your doctor.

This medication may also increase the risk of a severe brain condition called aseptic meningitis. If you experience any of the following symptoms, contact your doctor immediately: headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion.

In rare cases, drugs like this one have been associated with liver problems, which can be life-threatening. If you notice any signs of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain or nausea, pale stools, vomiting, or yellowing of the skin or eyes, contact your doctor right away.

If you are 60 years or older, use this medication with caution, as you may be more susceptible to side effects.

It is essential to note that NSAIDs like this drug may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. If you are concerned about fertility, discuss this with your doctor.

If you are breastfeeding, inform your doctor, as they will need to assess the potential risks to your baby and discuss alternative options with you.
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Overdose Information

Overdose Symptoms:

  • Severe stomach pain
  • Nausea
  • Vomiting
  • Drowsiness
  • Dizziness
  • Headache
  • Ringing in the ears (tinnitus)
  • Blurred vision
  • Nystagmus
  • Metabolic acidosis
  • Renal failure
  • Coma
  • Seizures

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage or activated charcoal may be considered if ingestion is recent (within 1 hour) and substantial. Monitor vital signs, renal function, and acid-base balance.

Drug Interactions

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Contraindicated Interactions

  • Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
  • Severe renal impairment
  • Severe hepatic impairment
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Heparin, Dabigatran): Increased risk of bleeding.
  • Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
  • Corticosteroids: Increased risk of GI ulceration and bleeding.
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced natriuretic and antihypertensive effects; increased risk of renal impairment.
  • ACE Inhibitors (e.g., Lisinopril) and Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan): Reduced antihypertensive effect; increased risk of renal impairment, especially in elderly or volume-depleted patients.
  • Lithium: Increased plasma lithium levels and risk of toxicity.
  • Methotrexate: Increased methotrexate levels and toxicity.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • Cyclosporine: Increased risk of nephrotoxicity.
  • Tacrolimus: Increased risk of nephrotoxicity.
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Moderate Interactions

  • Beta-blockers: Reduced antihypertensive effect.
  • Digoxin: May increase serum digoxin levels.
  • Phenytoin: May increase serum phenytoin levels.
  • Sulfonylureas: May enhance hypoglycemic effect.
  • Aminoglycosides: May increase aminoglycoside levels (by reducing renal clearance).
  • Pemetrexed: Increased risk of myelosuppression, renal, and GI toxicity (avoid in patients with creatinine clearance <80 mL/min).
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Minor Interactions

  • Alcohol: Increased risk of GI irritation/bleeding.
  • Ginkgo Biloba: Theoretical increased risk of bleeding.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To establish baseline for potential hematologic adverse effects (e.g., anemia, thrombocytopenia) with long-term use.

Timing: Before initiating long-term therapy.

Renal Function (BUN, Serum Creatinine, eGFR)

Rationale: To assess baseline kidney function, as NSAIDs can cause renal impairment.

Timing: Before initiating therapy, especially in patients with pre-existing renal impairment or risk factors.

Liver Function Tests (ALT, AST)

Rationale: To assess baseline liver function, as NSAIDs can cause hepatic injury.

Timing: Before initiating long-term therapy or in patients with pre-existing hepatic impairment.

Blood Pressure

Rationale: To establish baseline, as NSAIDs can cause new onset hypertension or worsen existing hypertension.

Timing: Before initiating therapy.

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Routine Monitoring

Renal Function (BUN, Serum Creatinine, eGFR)

Frequency: Periodically, especially with long-term use, high doses, or in patients with risk factors (e.g., elderly, heart failure, diuretic use).

Target: Within normal limits or stable from baseline.

Action Threshold: Significant increase in creatinine (>20% from baseline), decrease in eGFR; consider dose reduction or discontinuation.

Blood Pressure

Frequency: Regularly, especially in hypertensive patients.

Target: Individualized target BP.

Action Threshold: Sustained increase in BP; consider alternative analgesic or antihypertensive adjustment.

Signs/Symptoms of GI Bleeding (e.g., melena, hematemesis)

Frequency: Continuously, patient education is key.

Target: Absence of symptoms.

Action Threshold: Any signs of GI bleeding; discontinue ibuprofen and seek immediate medical attention.

Fluid Retention/Edema

Frequency: Regularly, especially in patients with heart failure or hypertension.

Target: Absence of significant edema or weight gain.

Action Threshold: Development of new or worsening edema; consider discontinuation.

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Symptom Monitoring

  • Abdominal pain
  • Indigestion (dyspepsia)
  • Heartburn
  • Nausea
  • Vomiting
  • Black, tarry stools (melena)
  • Vomit that looks like coffee grounds (hematemesis)
  • Unusual bruising or bleeding
  • Swelling of ankles, feet, or hands (edema)
  • Shortness of breath
  • Chest pain
  • Weakness or numbness on one side of the body
  • Slurred speech
  • Sudden severe headache
  • Skin rash, blistering, or peeling
  • Unexplained weight gain
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Flu-like symptoms (fever, body aches, headache, rash)

Special Patient Groups

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Pregnancy

Avoid use during pregnancy, especially in the third trimester, due to potential risks to the fetus. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Possible increased risk of miscarriage and congenital malformations (e.g., cardiac septal defects, gastroschisis), though data are conflicting and less robust than for third trimester.
Second Trimester: Similar risks as first trimester; generally considered Category C. Use with caution and only if clearly needed.
Third Trimester: Category D. Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and renal dysfunction leading to oligohydramnios and potential fetal renal impairment.
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Lactation

Considered compatible with breastfeeding. Ibuprofen is excreted into breast milk in very small amounts, and adverse effects in breastfed infants are unlikely.

Infant Risk: Low risk (L1)
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Pediatric Use

Dosing is weight-based for children. 600mg tablets are generally not suitable for young children due to high strength and difficulty in precise dosing. Lower strength formulations (e.g., suspensions, chewables) are available for pediatric use. Caution is advised in dehydrated children due to increased risk of renal adverse effects.

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Geriatric Use

Elderly patients are at increased risk for serious adverse effects, including gastrointestinal bleeding, renal impairment, and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor renal function and signs of GI bleeding closely.

Clinical Information

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Clinical Pearls

  • Always advise patients to take ibuprofen with food or milk to minimize GI upset and reduce the risk of gastric irritation/ulceration.
  • Educate patients on the signs of GI bleeding (black, tarry stools; coffee-ground vomit) and to seek immediate medical attention if these occur.
  • Remind patients that ibuprofen can increase blood pressure and should be used with caution in hypertensive patients, especially those on antihypertensive medications.
  • Counsel patients to avoid concomitant use of other NSAIDs (prescription or OTC) to prevent additive toxicity.
  • For patients with cardiovascular risk factors, consider alternative analgesics if possible, or use the lowest effective dose for the shortest duration.
  • In patients with renal impairment or those at risk (e.g., elderly, dehydrated, heart failure, on diuretics/ACEIs), monitor renal function closely.
  • Ibuprofen is generally preferred over naproxen for short-term, acute pain due to its shorter half-life and potentially lower risk of cardiovascular events with short-term use, though both carry risks.
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Alternative Therapies

  • Acetaminophen (Tylenol) - for pain and fever, no anti-inflammatory effect, different side effect profile (hepatic toxicity)
  • Naproxen (Aleve, Naprosyn) - another NSAID with longer half-life
  • Diclofenac (Voltaren) - another NSAID
  • Celecoxib (Celebrex) - COX-2 selective NSAID, potentially lower GI risk but similar cardiovascular risk
  • Aspirin (low dose for antiplatelet, higher dose for pain/inflammation)
  • Opioid analgesics (for severe pain, with significant risks and dependence potential)
  • Topical analgesics (e.g., topical NSAIDs, capsaicin, lidocaine patches) - for localized pain
  • Non-pharmacological therapies (e.g., RICE therapy for musculoskeletal injuries, physical therapy, heat/cold packs, massage, acupuncture)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (600mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.