IBUPROFEN TABLETS, USP
PRODUCT DETAILS
- Strength: Available in 400 mg, 600 mg, and 800 mg Tablets
- Therapeutic Class: NSAID
NDC Numbers:
400 mg | Bottle of 100: 70436-180-01
400 mg | Bottle of 500: 70436-180-02
600 mg | Bottle of 100: 70436-181-01
600 mg | Bottle of 500: 70436-181-02
800 mg | Bottle of 100: 70436-182-01
800 mg | Bottle of 500: 70436-182-02
Available through your wholesaler:
NDC: 70436-180-01
Cardinal Health: 5799721
McKesson: 2634327
Amerisource: 10271503
NDC: 70436-180-02
Cardinal Health: 5799739
McKesson: 2634335
Amerisource: 10271504
NDC: 70436-181-01
Cardinal Health: 5799747
McKesson: 2634343
Amerisource: 10271505
NDC: 70436-181-02
Cardinal Health: 5799754
McKesson: 2634350
Amerisource: 10271496
NDC: 70436-182-01
Cardinal Health: 5799762
McKesson: 2634368
Amerisource: 10271497
NDC: 70436-182-02
Cardinal Health: 5799770
McKesson: 2634376
Amerisource: 10271495
| Strength | NDC | Package Size |
|---|---|---|
| 400 mg | 70436-180-01 | Bottle of 100 |
| 400 mg | 70436-180-02 | Bottle of 500 |
| 600 mg | 70436-181-01 | Bottle of 100 |
| 600 mg | 70436-181-02 | Bottle of 500 |
| 800 mg | 70436-182-01 | Bottle of 100 |
| 800 mg | 70436-182-02 | Bottle of 500 |
Ibuprofen Tablets, USP are supplied as follows:
400 mg, White to off-white, oval shaped, biconvex film coated tablets, debossed with “157” on one side and plain on the other side.
600 mg, White to off-white, capsule shaped, biconvex film coated tablets, debossed with “152” on one side and plain on the other side.
800 mg, White to off-white, capsule shaped, biconvex film coated tablets, debossed with “151” on one side and plain on the other side.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F)
IMPORTANT SAFETY INFORMATION FOR: MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS, USP
WARNING: 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.
- Ibuprofen Tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
WARNING: 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 are at greater risk for serious gastrointestinal events.
Ibuprofen Tablets, USP are contraindicated:
- In patients with known hypersensitivity to ibuprofen.
- In patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
- In the setting of coronary artery bypass graft.
NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. NSAIDs, including ibuprofen tablets, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Avoid the use of ibuprofen tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ibuprofen tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
NSAIDs, including ibuprofen tablets, can cause serious skin adverse events such as exfoliative
dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be
fatal. These serious events may occur without warning. Patients should be informed about the signs
and symptoms of serious skin manifestations and use of the drug should be discontinued at the first
appearance of skin reaction or any other sign of hypersensitivity.
The most common adverse reactions include nausea, epigastric pain, heartburn, dizziness, and rash.
Please see the package insert for Ibuprofen Tablets, USP for full prescribing information.