Gc 791

Gc 791
SPL v6
SPL
SPL Set ID e07aebe8-3c58-4bf0-9e80-66d430e2de9b
Route
ORAL
Published
Effective Date 2022-04-11
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 Starch, Corn Crospovidone Magnesium Stearate Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;137 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-02-10
Description

Simethicone 80 mg

Purpose

Anti-Gas

Medication Information

Purpose

Anti-Gas

Description

Simethicone 80 mg

Uses

relieves pressure, bloating, and fullness

commonly referred to as gas

Section 50565-1

Keep out of reach of children.

Warnings

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

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
Package Label

Other Information
  • each tablet contains: calcium 65 mg
  • 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

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

magnesium stearate, silica, sucralose, calcium phosphate.

Questions Or Comments?

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Active Ingredient (in Each Tablet)

Simethicone 80 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

Anti-Gas

Warnings

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

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
Package Label (package Label)

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 room temperature, 15°C - 30°C (59˚F - 86˚F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

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

magnesium stearate, silica, sucralose, calcium phosphate.

Questions Or Comments? (Questions or comments?)

DISTRIBUTED BY: 

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Simethicone 80 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:13.775992 · Updated: 2026-03-14T23:00:36.247175