Simethicone Capsules 250 Mg, Liquid Filled

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (250 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC31 Shape: capsule Color: purple Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-01-28

Medication Information

Purpose

Anti-gas

Description

Simethicone 250 mg

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Section 50565-1

Keep out of reach of children.

Warnings

Directions

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Stop Use and Ask A Doctor If

condition persists

Active Ingredient (in Each Capsule)

Simethicone 250 mg

Principal Display Panel Shipping Label

SIMETHICONE CAPSULES, 250 mg

Quantity : 25000 Capsules

NDC. No : 53345-032-01

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

relieves bloating, pressure or fullness commonly referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Anti-gas

Warnings

Directions

swallow one or two softgels after a meal
do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information (Other information)

store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients (Inactive ingredients)

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists

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

Simethicone 250 mg

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

SIMETHICONE CAPSULES, 250 mg

Quantity : 25000 Capsules

NDC. No : 53345-032-01

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": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses ": "relieves bloating, pressure or fullness commonly referred to as gas", "50565-1": "Keep out of reach of children.", "Purpose": "Anti-gas", "Directions": "swallow one or two softgels after a meal do not exceed two softgels per 24 hours except under the advice and supervision of a physician", "Other information": "store at room temperature 59°-86°F (15°-30°C)", "Inactive ingredients": "FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Wuhan, Hubei 430206, China", "Stop use and ask a doctor if": "condition persists", "Active ingredient (in each capsule)": "Simethicone 250 mg", "PRINCIPAL DISPLAY PANEL - Shipping Label": "SIMETHICONE CAPSULES, 250 mg Quantity : 25000 Capsules NDC. No : 53345-032-01 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 250 Mg, Liquid Filled

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information