SPL v1
SPL
SPL Set ID c1b88a30-ffeb-431c-ab73-728cdc786de0
Route
ORAL
Published
Effective Date 2025-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Crospovidone D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Fd&c Red No. 40 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Starch, Corn Sucralose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Imprint: 44;608 Shape: round Color: pink Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01

Description

Simethicone 125 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 125 mg

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Directions
  • adults:chew one or two tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
Questions?

call toll free 1-844-912-4012

Other Information
  • each tablet contains:calcium 85 mg
  • TAMPER EVIDENT:DO NOT USE IF SEAL AROUN TABLET IS BROKEN OR DAMAGED
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate.

Principal Display Panel

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Simethicone 125 mg


Structured Label Content

Uses

for the relief of pressure, bloating, and fullness commonly referred to as gas

Purpose

Antigas

Directions
  • adults:chew one or two tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
Questions?

call toll free 1-844-912-4012

Other Information (Other information)
  • each tablet contains:calcium 85 mg
  • TAMPER EVIDENT:DO NOT USE IF SEAL AROUN TABLET IS BROKEN OR DAMAGED
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate.

Principal Display Panel

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or a Poison Control Center (1-800-222-1222) right away.

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

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

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