Simethicone 180 Mg Capsule, Liquid Filled

SPL v3

SPL

SPL Set ID 2cfb8132-6de4-457d-880b-c870a38862ad

Route

ORAL

Published

Effective Date 2019-11-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone 410 (180 mg)

Inactive Ingredients

Silicon Dioxide Fd&c Yellow No. 6 Gelatin Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC3 Shape: capsule Color: orange Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-04-15

Description

Simethicone 180 mg

Purpose

Antiflatulent

Medication Information

Purpose

Antiflatulent

Description

Simethicone 180 mg

Uses

bloating
pressure
fullness
stuffed feeling commonly referred to as gas

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Warnings

Stop use and ask a doctorif condition persists.

Directions

swallow 1 or 2 softgels as needed after meals
do not exceed 2 softgels per day unless directed by doctor

Other Information

store at controlled room temperature 15°-30°C (59°-86°F)
protect from heat and moisture
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water, sorbitol special and white edible ink.

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

Active Ingredient (in Each Capsule)

Simethicone 180 mg

Principal Display Panel Shipping Label

SIMETHICONE CAPSULES,180 mg

Quantity : 25000 Capsules

NDC. No : 53345-003-03

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

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

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Structured Label Content

Uses

bloating
pressure
fullness
stuffed feeling commonly referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Purpose

Antiflatulent

Warnings

Stop use and ask a doctorif condition persists.

Directions

swallow 1 or 2 softgels as needed after meals
do not exceed 2 softgels per day unless directed by doctor

Other Information (Other information)

store at controlled room temperature 15°-30°C (59°-86°F)
protect from heat and moisture
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

FD&C yellow#6, gelatin, glycerin, purified water, sorbitol special and white edible ink.

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei

430206, China

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

Simethicone 180 mg

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

SIMETHICONE CAPSULES,180 mg

Quantity : 25000 Capsules

NDC. No : 53345-003-03

IMPORTANT:

Inspect immediate upon receipt.

This is a bulk shipment intended for further processing only.

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

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "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 410", "unii": "TYU5GP6XGE", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "bloating pressure fullness stuffed feeling commonly referred to as gas", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health care professional before use. ", "Purpose": "Antiflatulent", "Warnings": "Stop use and ask a doctor if condition persists.", "Directions": "swallow 1 or 2 softgels as needed after meals do not exceed 2 softgels per day unless directed by doctor", "Other information": "store at controlled room temperature 15°-30°C (59°-86°F) protect from heat and moisture do not use if imprinted safety seal under cap is broken or missing", "Inactive ingredients": "FD&C yellow#6, gelatin, glycerin, purified water, sorbitol special and white edible ink. Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China", "Active ingredient (in each capsule)": "Simethicone 180 mg", "PRINCIPAL DISPLAY PANEL - Shipping Label": "SIMETHICONE CAPSULES,180 mg Quantity : 25000 Capsules NDC. No : 53345-003-03 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING""}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:30.761701 · Updated: 2026-03-14T23:05:18.894850