Gc 694

Gc 694
SPL v4
SPL
SPL Set ID b6223134-8a2e-d1ec-e053-2995a90a9077
Route
ORAL
Published
Effective Date 2016-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Sucrose Maltodextrin Sorbitol Silicon Dioxide Stearic Acid Dextrose Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: AP040 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Simethicone 125 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125 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 4 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)
  • protect from moisture
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 125 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

Antigas

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 4 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)
  • protect from moisture
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 125 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)