ANTIFLATULENT — dimethicone 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.
Simethicone 80 mg
- symptoms referred to as gas
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
- chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
- do not exceed 6 tablets per day unless directed by a physician
- do not use if inner seal is broken
- store at room temperature
- avoid high humidity and excessive heat, above 40o C (104o F)
Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with “G and 103” on one side and are supplied as:
NDC 0904-7206-60 in bottle of 100 chewable tablets
Livonia, MI 48152
compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.
Call (800) 616-2471
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:
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.
Cookeville, TN 38506
NDC 71610-650 — Simethicone 80 mg Chewable Tablet — Rx Only
| ANTIFLATULENT |
simethicone tablet, chewable
|Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)|
|Aphena Pharma Solutions — Tennessee, LLC||128385585||REPACK (71610-650)|
Revised: 06/2022 Aphena Pharma Solutions — Tennessee, LLC
Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.