SIMETHICONE- 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
relieves pressure, bloating, and fullness
commonly referred to as gas
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children.
- chew or crush tablet completely before swallowing
- adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.
Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.
- children under 12 years: ask a doctor
- each tablet contains: calcium 65 mg
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
- store at room temperature, 15°C — 30°C (59˚F — 86˚F)
- protect from moisture
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
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:
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 71610-649 — Simethicone 80 mg Chewable Tablet — Rx Only
| SIMETHICONE |
simethicone tablet, chewable
|Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)|
|Aphena Pharma Solutions — Tennessee, LLC||128385585||REPACK (71610-649)|
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.