Major Simethicone

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (80 mg)

Inactive Ingredients

Sugarcane Maltodextrin Dextrose, Unspecified Form Magnesium Stearate Microcrystalline Cellulose Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: G;103 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-10-04

Medication Information

Purpose

Antigas

How Supplied

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

Distributed by:

Major Pharmaceuticals

Livonia, MI 48152

Description

Simethicone 80 mg

Use(s)

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

.

Questions

Call (800) 616-2471

Directions

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

Other Information

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40 ^oC (104 ^oF)

Inactive Ingredients

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

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:

Count	80 mg
4	71610-650-04

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Principal Display Panel 80 Mg

NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only

Active Ingredient(in Each Tablet)

Simethicone 80 mg

Structured Label Content

Use(s) (USE(S))

relieves:

pressure
bloating
symptoms referred to as gas

Purpose (PURPOSE)

Antigas

Warnings (WARNINGS)

.

Questions (QUESTIONS)

Call (800) 616-2471

Directions (DIRECTIONS)

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

How Supplied (HOW SUPPLIED)

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

Distributed by:

Major Pharmaceuticals

Livonia, MI 48152

Other Information (OTHER INFORMATION)

do not use if inner seal is broken
store at room temperature
avoid high humidity and excessive heat, above 40 ^oC (104 ^oF)

Inactive Ingredients (INACTIVE INGREDIENTS)

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

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:

Count	80 mg
4	71610-650-04

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Principal Display Panel 80 Mg (PRINCIPAL DISPLAY PANEL - 80 mg)

NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only

Active Ingredient(in Each Tablet) (ACTIVE INGREDIENT(in each tablet))

Simethicone 80 mg

Advanced Ingredient Data

[{"name": "SUGARCANE", "unii": "81H2R5AOH3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "relieves: pressure bloating symptoms referred to as gas", "PURPOSE": "Antigas", "WARNINGS": ".", "QUESTIONS": "Call (800) 616-2471", "DIRECTIONS": "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", "HOW SUPPLIED": "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 Distributed by: Major Pharmaceuticals Livonia, MI 48152", "OTHER INFORMATION": "do not use if inner seal is broken store at room temperature avoid high humidity and excessive heat, above 40 o C (104 o F)", "INACTIVE INGREDIENTS": "compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.", "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: Count 80 mg 4 71610-650-04 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", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. ", "PRINCIPAL DISPLAY PANEL - 80 mg": "NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only", "ACTIVE INGREDIENT(in each tablet)": "Simethicone 80 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information