Simethicone Capsules 125 Mg, Liquid Filled

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 D&c Yellow No. 10 Gelatin Glycerin Peppermint Oil Water

Identifiers & Packaging

Pill Appearance

Imprint: 664 Shape: capsule Color: green Size: 10 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-01-28

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for relief of

pressure, bloating, and fullness commonly referred to as gas

Section 50565-1

Keep out of reach of children.

Warnings

Directions

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

store at room temperature 15°-30°C (59°-86°F)
protect from light, heat and moisture

Inactive Ingredients

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Active Ingredient (in Each Capsule)

Simethicone 125 mg

Principal Display Panel Shipping Label

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules

NDC. No : 53345-033-01

IMPORTANT:

1.Inspect immediate upon receipt.

2.This is a bulk shipment, intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Structured Label Content

Uses

for relief of

pressure, bloating, and fullness commonly referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antigas

Warnings

Directions

adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information (Other information)

store at room temperature 15°-30°C (59°-86°F)
protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Simethicone 125 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules

NDC. No : 53345-033-01

IMPORTANT:

1.Inspect immediate upon receipt.

2.This is a bulk shipment, intended for further processing only.

3.Protect from heat, humidity, and light. Do not refrigerate.

4.Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses ": "for relief of pressure, bloating, and fullness commonly referred to as gas", "50565-1": "Keep out of reach of children.", "Purpose": "Antigas", "Directions": "adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician", "Other information": "store at room temperature 15°-30°C (59°-86°F) protect from light, heat and moisture", "Inactive ingredients": "D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Wuhan, Hubei 430206, China", "Active ingredient (in each capsule)": "Simethicone 125 mg", "PRINCIPAL DISPLAY PANEL - Shipping Label": "SIMETHICONE CAPSULES, 125 mg Quantity : 25000 Capsules NDC. No : 53345-033-01 IMPORTANT: 1.Inspect immediate upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light. Do not refrigerate. 4.Store at 15-30°C (59-86°F) CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"}

Simethicone Capsules 125 Mg, Liquid Filled

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information