Gc 791a (799)

Gc 791a (799)
SPL v1
SPL
SPL Set ID 3ef70a20-835e-4476-80fc-4bb4b150a8a6
Route
ORAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (80 mg)
Inactive Ingredients
Dextrose, Unspecified Form Silicon Dioxide Sorbitol Stearic Acid Microcrystalline Cellulose Maltodextrin Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: AP019 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-01
Description

Simethicone 80 mg

Purpose

Anti-Gas

Medication Information

Purpose

Anti-Gas

Description

Simethicone 80 mg

Uses

for the relief of

  • •
    pressure, bloating, and fullness commonly referred to as gas
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

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

Directions

• chew thoroughly

• 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
  • •
    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)
Inactive Ingredients

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

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Tablet)

Simethicone 80 mg

Structured Label Content

Uses

for the relief of

  • •
    pressure, bloating, and fullness commonly referred to as gas
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Anti-Gas

Warnings

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

Directions

• chew thoroughly

• 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)
  • •
    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)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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: 2026-02-15T12:02:46.965150 · Updated: 2026-03-14T23:02:29.359860