OTC Medication Information: SIMETHICONE

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.

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

relieves pressure, bloating, and fullness
commonly referred to as gas

Warnings

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Directions

  • 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

Other information

  • 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

HOW SUPPLIED

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

Inactive ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

1-800-540-3765

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:

Count80 mg
471610-649-04

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:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20220519JK

PRINCIPAL DISPLAY PANEL — 80 mg

NDC 71610-649 — Simethicone 80 mg Chewable Tablet — Rx Only

Bottle Label 80 mg
(click image for full-size original)

SIMETHICONE
simethicone tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-649(NDC:57896-791)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 80 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DEXTRATES
SILICON DIOXIDE
TRICALCIUM PHOSPHATE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
SUCRALOSE
Product Characteristics
Color white Score no score
Shape ROUND Size 13mm
Flavor PEPPERMINT Imprint Code 44;137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-649-04 4 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 01/01/2004
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
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.

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.

Terms of Use | Copyright © 2022. All Rights Reserved.