SPL v3
SPL
SPL Set ID 0f9639fa-e1d0-460d-bc46-714a01cd9811
Route
ORAL
Published
Effective Date 2019-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 1 Fd&c Red No. 40 D&c Yellow No. 10 Gelatin Glycerin Peppermint Oil Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: PC2 Shape: capsule Color: green Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-15
Description

Simethicone 125 mg

Purpose

Antiflatulent

Medication Information

Purpose

Antiflatulent

Description

Simethicone 125 mg

Uses
  • bloating
  • pressure
  • fullness
  • stuffed feeling commonly referred to as gas
Section 34088-5

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor ifcondition persists.

Section 53414-9

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

Warnings

Directions
  • adults:swallow with water 1 or 2 softgels as needed after meals or at bedtime
  • do not exceed 4 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

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

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) 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 : 53345-009-01

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 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcondition persists.

Section 53414-9 (53414-9)

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

Purpose

Antiflatulent

Warnings

Directions
  • adults:swallow with water 1 or 2 softgels as needed after meals or at bedtime
  • do not exceed 4 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)

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide 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 125 mg

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

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules

NDC. No : 53345-009-01

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:29.143110 · Updated: 2026-03-14T23:05:15.511736