Gc792s (292)

Gc792s (292)
SPL v5
SPL
SPL Set ID b6701200-eb58-30f1-e053-2a95a90a032e
Route
ORAL
Published
Effective Date 2016-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: SCU Shape: oval Color: green Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01
Description

Simethicone 125 mg

Purpose

Antigas

Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

relieves pressure, bloating, and fullness commonly referred to as gas

Section 50565-1

Keep out of reach of children.

Directions
  • adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime
  • do not exceed 4 capsules in 24 hours unless directed by a doctor
Package Label

Other Information
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • Product of Romania
  • store at 20°-25°C (68°-77°F); excursions permitted between 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, sorbitol special, titanium dioxide

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Liquid Filled Capsule)

Simethicone 125 mg

Structured Label Content

Uses

relieves pressure, bloating, and fullness commonly referred to as gas

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Antigas

Directions
  • adults: swallow with water 1 or 2 capsules as needed after meals and at bedtime
  • do not exceed 4 capsules in 24 hours unless directed by a doctor
Package Label (package label)

Other Information (Other information)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • Product of Romania
  • store at 20°-25°C (68°-77°F); excursions permitted between 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, sorbitol special, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredient (in Each Liquid Filled Capsule) (Active ingredient (in each liquid-filled capsule))

Simethicone 125 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:37.745549 · Updated: 2026-03-14T23:11:16.641314