c1b88a30-ffeb-431c-ab73-728cdc786de0

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
Purpose

Antigas

Description

Simethicone 125 mg

Medication Information

Active Ingredient

Simethicone 125 mg

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
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.

Description

Simethicone 125 mg

Principal Display Panel

Questions?

call toll free 1-844-912-4012

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.

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Simethicone 125 mg

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
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

Questions?

call toll free 1-844-912-4012

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:04.820626 · Updated: 2026-03-14T23:10:14.816739