Description
NDC: 59651-362-01
Ibuprofen 800 mg Tablets, 100 count — Aurobindo Pharma
| Active ingredient | Ibuprofen 800 mg |
| Dosage form | Tablet (film-coated) |
| Route | Oral |
| Size | 100 count |
| Manufacturer | Aurobindo Pharma |
| NDC | 59651-362-01 |
Indications and Usage
A nonsteroidal anti-inflammatory drug indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis, for management of mild to moderate pain, and for treatment of primary dysmenorrhea. The lowest effective dose should be used for the shortest duration consistent with treatment goals.
Dosage and Administration
For rheumatoid arthritis and osteoarthritis, the usual dosage is 1200 to 3200 mg daily in divided doses. For mild to moderate pain, 400 mg every 4 to 6 hours as needed; for dysmenorrhea, 400 mg every 4 hours as needed. The maximum daily dose is 3200 mg.
Warnings and Precautions
- Boxed Warning: NSAIDs increase the risk of serious cardiovascular thrombotic events, including fatal myocardial infarction and stroke, and are contraindicated for peri-operative pain in coronary artery bypass graft surgery
- Boxed Warning: NSAIDs increase the risk of serious gastrointestinal bleeding, ulceration, and perforation, which can be fatal and can occur without warning
- May cause new-onset or worsening hypertension, fluid retention, edema, and heart failure
- Can cause renal injury, serious skin reactions, anaphylactoid reactions, and fetal harm; avoid use at about 30 weeks gestation and later
Contraindications
Contraindicated in patients with known hypersensitivity to ibuprofen, in those who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs, and in the setting of coronary artery bypass graft surgery.
Adverse Reactions
Common adverse reactions include nausea, epigastric pain, heartburn, dizziness, headache, and rash. Serious adverse reactions include gastrointestinal hemorrhage and ulceration, hepatitis, acute renal failure, anaphylaxis, and severe skin reactions.
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); avoid exposure to excessive heat above 40°C.
How Supplied
Supplied as 800 mg capsule-shaped film-coated tablets in bottles of 100 tablets.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
