gas relief simethicone 125mg softgel

gas relief simethicone 125mg softgel
SPL v2
SPL
SPL Set ID b774c8e6-e68e-4a13-834d-7eba34c5c3e0
Route
oral
Published
Effective Date 2024-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
peppermint oil gelatin sorbitol sorbitan glycerin fd&c blue no. 1 titanium dioxide d&c yellow no. 10

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-18
Purpose

Antigas

Description

Simethicone 125 mg

Medication Information

Warnings

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

Purpose

Antigas

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at 15° to 30°C (59° to 86°F)
  • protect from light, heat, and moisture
Inactive Ingredients

Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

Description

Simethicone 125 mg

Use

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

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

Questions Or Comments?

Call 1 (718) 337-8733 or visit [email protected]

Active Ingredient (in Each Softgel)

Simethicone 125 mg

Structured Label Content

Warnings

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

Purpose

Antigas

Directions
  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
  • store at 15° to 30°C (59° to 86°F)
  • protect from light, heat, and moisture
Inactive Ingredients

Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

Use

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Questions Or Comments? (Questions or Comments?)

Call 1 (718) 337-8733 or visit [email protected]

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

Simethicone 125 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:49.914468 · Updated: 2026-03-14T23:11:42.520832