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
Purpose

Anti-Gas

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

Anti-Gas

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
  • 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.

Description

Simethicone 80 mg

Section 50565-1

Keep out of reach of children.

Package Label

Questions Or Comments?

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

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

Anti-Gas

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
  • 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Package Label (package Label)

Questions Or Comments? (Questions or comments?)

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

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