SIMETHICONE- simethicone tablet, chewable
Aphena Pharma Solutions - Tennessee, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.
Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "44 & 137" on one side and are supplied as:
NDC 57896-791-01 in bottle of 100 chewable tablets
NDC 57896-791-08 in bottle of 80 chewable tablets
Distributed by:
GERI-CARE Pharmaceuticals Corp.
1650 63rd Street, Brooklyn, NY 11204
cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.
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 | 80 mg |
4 | 71610-649-04 |
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
20220519JK
SIMETHICONE
simethicone tablet, chewable |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(71610-649) |