drug facts

drug facts
SPL v1
SPL
SPL Set ID 0c1467f3-dab6-353b-e054-00144ff8d46c
Route
oral
Published
Effective Date 2014-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c yellow no. 5 gelatin glycerin water titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: GR Shape: oval Color: green Size: 9 mm Score: 1
Marketing Status
otc monograph final active Since 2014-01-08
Purpose

Antiflatulent

Description

Simethicone 125mg

Medication Information

Uses

For Relief of:

  • Bloating
  • Pressure
  • Fullness
  • stuffed feeling commonly referred to as gas
Purpose

Antiflatulent

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor.
Other Information
  • store at a controlled room temperature 15-30°C (59-86°F)
  • protect from heat and moisture
Description

Simethicone 125mg

Inactive Ingreients

FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide

Stop Use and Ask A Doctor If

condition persists

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Active Ingredients (in Each Softgel)

Simethicone 125mg

Package/label Principal Display Panel

Structured Label Content

Uses

For Relief of:

  • Bloating
  • Pressure
  • Fullness
  • stuffed feeling commonly referred to as gas
Purpose

Antiflatulent

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by doctor.
Other Information (Other information)
  • store at a controlled room temperature 15-30°C (59-86°F)
  • protect from heat and moisture
Inactive Ingreients (Inactive ingreients)

FD&C blue 1, FD&C yellow 5, gelatin, glycerin, purified water, titanium dioxide

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition persists

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

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

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

ask a health care professional before use.

Active Ingredients (in Each Softgel) (Active Ingredients (in each softgel))

Simethicone 125mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:53.026271 · Updated: 2026-03-14T22:53:55.198203