20935a7f-41dd-93c5-e063-6294a90aa1c4

SPL v1

SPL

SPL Set ID 20935a7f-41dd-93c5-e063-6294a90aa1c4

Route

oral

Published

Effective Date 2024-08-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (180 mg)

Inactive Ingredients

water glycerin fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance

Shape: capsule Color: orange Size: 10 mm

Marketing Status

otc monograph drug active Since 2024-08-26

Purpose

Anti-gas

Description

Simethicone 180 mg

Medication Information

Warnings

Stop use and ask a doctorif condition persists

Keep out of reach of children.

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Anti-gas

Directions

swallow one or two softgels as needed after a meal

do not exceed two softgels per day except under the advice and supervision of a physician

Other Information

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Description

Simethicone 180 mg

Section 51945-4

Keep Out of Reach of Children

Keep out of reach of children.

Active Ingredient (in Each Capsule)

Simethicone 180 mg

Structured Label Content

Warnings

Stop use and ask a doctorif condition persists

Keep out of reach of children.

Uses

relieves bloating, pressure or fullness commonly referred to as gas

Purpose

Anti-gas

Directions

swallow one or two softgels as needed after a meal

do not exceed two softgels per day except under the advice and supervision of a physician

Other Information (Other information)

store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients (Inactive ingredients)

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Section 51945-4 (51945-4)

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

Keep out of reach of children.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Simethicone 180 mg

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating, pressure or fullness commonly referred to as gas", "Purpose": "Anti-gas", "Warnings": "Stop use and ask a doctorif condition persists Keep out of reach of children.", "Directions": "swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician", "Other information": "store at room temperature 59º - 86ºF (15º - 30ºC)", "Inactive ingredients": "FD&C yellow#6, gelatin, glycerin, purified water and white edible ink", "keep out of reach of children": "Keep out of reach of children.", "Active ingredient (in each capsule)": "Simethicone 180 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:29.153251 · Updated: 2026-03-14T23:03:33.890868