gc 694

gc 694
SPL v4
SPL
SPL Set ID b6223134-8a2e-d1ec-e053-2995a90a9077
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
sucrose maltodextrin sorbitol silicon dioxide stearic acid dextrose microcrystalline cellulose

Identifiers & Packaging

Pill Appearance
Imprint: AP040 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
otc monograph drug active Since 2020-03-01
Purpose

Antigas

Description

Simethicone 125 mg

Medication Information

Warnings

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

Active Ingredient

Simethicone 125 mg

Uses

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

Purpose

Antigas

Directions
  • chew or crush tablet completely before swallowing
  • adults and children 12 years and over: take 1-2

tablets as needed after meals and at bedtime. Do

not exceed 4 tablets in 24 hours except under the

advice and supervision of a doctor.

  • children under 12 years: ask a doctor
Other Information
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at room temperature, 15°C-30°C (59°F-86°F)
  • protect from moisture
Inactive Ingredients

dextrose, sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silica, sorbitol, stearic acid

Description

Simethicone 125 mg

Section 50565-1

Keep out of reach of children.

Package Label

Questions Or Comments?

1-800-540-3765

Structured Label Content

Warnings

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

Active Ingredient (Active ingredient (in each tablet))

Simethicone 125 mg

Uses

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

Purpose

Antigas

Directions
  • chew or crush tablet completely before swallowing
  • adults and children 12 years and over: take 1-2

tablets as needed after meals and at bedtime. Do

not exceed 4 tablets in 24 hours except under the

advice and supervision of a doctor.

  • children under 12 years: ask a doctor
Other Information (Other information)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at room temperature, 15°C-30°C (59°F-86°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

dextrose, sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silica, sorbitol, stearic acid

Section 50565-1 (50565-1)

Keep out of reach of children.

Package Label (package label)

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:16.182628 · Updated: 2026-03-14T23:10:32.676275