The following Structured Product Label (SPL) was submitted to the FDA by Aphena Pharma Solutions - Tennessee, Llc for the product Ibuprofen (NDC 71610-532). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding ibuprofen tablets 400 mg - 600 mg- 800 mg medguide, how supplied, repackaging information, principal display panel - 600 mg, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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)
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:
Aphena Pharma Solutions (TN)
NDC 71610-532 - Ibuprofen, USP 600 mg Tablets - Rx Only
Bottle Label 600 mg (71610 0532 60)
* Please review the disclaimer below.
