simethicone capsules 180 mg

SPL v2

SPL

SPL Set ID dde179ec-fece-4cdc-b68b-c217acfa9ac8

Route

oral

Published

Effective Date 2012-05-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (180 mg)

Inactive Ingredients

fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin

Identifiers & Packaging

Pill Appearance

Imprint: RP112 Shape: oval Color: red Size: 8 mm Score: 1

Marketing Status

otc monograph final active Since 2012-01-15

Purpose

Antigas

Description

Simethicone 180 mg

Medication Information

Warnings

Stop use and ask doctor if condition persists

Uses

Relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Antigas

Directions

Swallow one or two softgels as needed after a meal
Do not exceed two softgels per day except under the advise and supervision of a physician

Other Information

Each softgel contains: potassium 5 mg
Store at 20⁰ - 25⁰C

Description

Simethicone 180 mg

Section 50565-1

Keep out of Reach of Children

Section 51945-4

Inactive Ingredients:

FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol

Active Ingredient (in Each Softgel)

Simethicone 180 mg

Structured Label Content

Warnings

Stop use and ask doctor if condition persists

Uses

Relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Antigas

Directions

Swallow one or two softgels as needed after a meal
Do not exceed two softgels per day except under the advise and supervision of a physician

Other Information

Each softgel contains: potassium 5 mg
Store at 20⁰ - 25⁰C

Section 50565-1 (50565-1)

Keep out of Reach of Children

Section 51945-4 (51945-4)

Inactive Ingredients: (Inactive ingredients:)

FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol

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

Simethicone 180 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Relieves bloating, pressure or fullness commonly referred to as gas", "50565-1": "Keep out of Reach of Children", "Purpose": "Antigas", "Warnings": "Stop use and ask doctor if condition persists", "Directions": "Swallow one or two softgels as needed after a meal Do not exceed two softgels per day except under the advise and supervision of a physician", "Other Information": "Each softgel contains: potassium 5 mg Store at 20 0 - 25 0 C", "Inactive ingredients:": "FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol", "Active ingredient (in each softgel)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.234228 · Updated: 2026-03-14T22:53:10.919261