FDA Label for Ibuprofen
View Indications, Usage & Precautions
Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
How Supplied
400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500
600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500
800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 600 mg |
| 90 | 71610-532-60 |
| 180 | 71610-532-80 |
| 270 | 71610-532-92 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20210420JH
Principal Display Panel - 600 Mg
NDC 71610-532 - Ibuprofen, USP 600 mg Tablets - Rx Only
* Please review the disclaimer below.