Fos 791

Fos 791
SPL v2
SPL
SPL Set ID ff1fd97c-af4f-dffb-e053-6294a90a2039
Route
ORAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (80 mg)
Inactive Ingredients
Dextrates Silicon Dioxide Tricalcium Phosphate Sucralose Starch, Corn Crospovidone Magnesium Stearate Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: 44;137 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01
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
  • store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients

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

magnesium stearate, silica, sucralose, calcium phosphate.

Questions Or Comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

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
  • store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)
  • protect from moisture
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

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

magnesium stearate, silica, sucralose, calcium phosphate.

Questions Or Comments? (Questions or comments?)

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

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

Simethicone 80 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:09.302632 · Updated: 2026-03-14T23:01:33.532889