433 - gas relief

SPL v5

SPL

SPL Set ID 4c79535c-4372-4fd4-a91a-d93617cd581b

Route

oral

Published

Effective Date 2021-09-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (180 mg)

Inactive Ingredients

fd&c yellow no. 6 gelatin glycerin water

Identifiers & Packaging

Pill Appearance

Imprint: PC3 Shape: oval Color: orange Size: 10 mm Score: 1

Marketing Status

otc monograph drug active Since 2012-02-01

Purpose

Anti-gas

Description

Simethicone 180 mg

Medication Information

Purpose

Anti-gas

Directions

Swallow 1 or 2 softgels as symptoms

occur
Do not exceed 2 softgels in 24 hours

except under the advice and

supervision of a physician.

Other Information

Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

FD&C yellow # 6, gelatin, glycerin,

purified water and white edible ink

Description

Simethicone 180 mg

Principal Display Panel

Gas Relief

Use(s)

Relieves bloating, pressure or fullness commonly referred to as gas

Storage

store at room temperature (59°– 86°F) 15°– 30°C

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s)

Simethicone 180 mg

Stop Use and Ask A Doctor If

condition persists.

Structured Label Content

Purpose

Anti-gas

Directions

Swallow 1 or 2 softgels as symptoms

occur
Do not exceed 2 softgels in 24 hours

except under the advice and

supervision of a physician.

Other Information (Other information)

Do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

FD&C yellow # 6, gelatin, glycerin,

purified water and white edible ink

Principal Display Panel

Gas Relief

Use(s)

Relieves bloating, pressure or fullness commonly referred to as gas

Storage

store at room temperature (59°– 86°F) 15°– 30°C

Questions

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s) (Active ingredient(s))

Simethicone 180 mg

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

condition persists.

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "Relieves bloating, pressure or fullness commonly referred to as gas", "Purpose": "Anti-gas", "Storage": "store at room temperature (59°– 86°F) 15°– 30°C", "Questions": "Call 1-888-952-0050 Monday through Friday 9AM - 5PM", "Directions": "Swallow 1 or 2 softgels as symptoms occur Do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician.", "Other information": "Do not use if imprinted safety seal under cap is broken or missing", "Active ingredient(s)": "Simethicone 180 mg", "Inactive ingredients": "FD&C yellow # 6, gelatin, glycerin, purified water and white edible ink", "Principal Display Panel": "Gas Relief", "Stop use and ask a doctor if": "condition persists."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:38.472130 · Updated: 2026-03-14T23:05:32.543899