9889575e-6ea3-437a-99e9-f6fe8bcecf25

SPL v1
SPL
SPL Set ID 9889575e-6ea3-437a-99e9-f6fe8bcecf25
Route
oral
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (125 mg)
Inactive Ingredients
peppermint oil gelatin water polysorbate 20 glycerin fd&c blue no. 1 titanium dioxide d&c yellow no. 10

Identifiers & Packaging

Pill Appearance
Imprint: 911 Shape: oval Color: green Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-04-01

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 20° to 25°C (68° to 776°F)
  • protect from light, heat, and moisture
Inactive Ingredients

D&C Yellow 10, edible ink, FD&C blue 1, gelatin, glycerin, peppermint oil, polysorb,  purified water, titanium dioxide.

Description

Simethicone 125 mg

Questions?

Call toll-free 1-844-912-4012

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

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 20° to 25°C (68° to 776°F)
  • protect from light, heat, and moisture
Inactive Ingredients

D&C Yellow 10, edible ink, FD&C blue 1, gelatin, glycerin, peppermint oil, polysorb,  purified water, titanium dioxide.

Questions?

Call toll-free 1-844-912-4012

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)

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

Simethicone 125 mg


Advanced Ingredient Data


Raw Label Data

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