gc 791

gc 791
SPL v7
SPL
SPL Set ID be96ce05-dd74-4915-9a8f-2a1b34e2f158
Route
oral
Published
Effective Date 2013-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (80 mg)
Inactive Ingredients
cellulose, microcrystalline dextrates silicon dioxide tricalcium phosphate sucralose starch, corn crospovidone magnesium stearate

Identifiers & Packaging

Pill Appearance
Imprint: 44;137 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2004-01-01
Purpose

antigas

Description

Simethicone 80 mg

Medication Information

Warnings

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

Active Ingredient

Simethicone 80 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 6 tablets in 24 hours except under the advice and supervision of a doctor.

  • children under 12 years: ask a doctor
Other Information
  • each tablet contains: calcium 65 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,

magnesium stearate, silica, sucralose, tricalcium phosphate.

Description

Simethicone 80 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 80 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 6 tablets in 24 hours except under the advice and supervision of a doctor.

  • children under 12 years: ask a doctor
Other Information (Other information)
  • each tablet contains: calcium 65 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,

magnesium stearate, silica, sucralose, tricalcium phosphate.

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: 2026-02-15T12:07:16.187420 · Updated: 2026-03-14T23:10:32.676275