419- anti gas

SPL v5

SPL

SPL Set ID e99f2041-2543-4331-9f54-9eea179f94d2

Route

oral

Published

Effective Date 2020-10-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (125 mg)

Inactive Ingredients

d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 gelatin glycerin peppermint oil water

Identifiers & Packaging

Pill Appearance

Shape: oval Color: green Size: 10 mm Score: 1

Marketing Status

otc monograph drug active Since 2015-01-28

Purpose

Anti gas

Description

Simethicone 125mg

Medication Information

Purpose

Anti gas

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

Do not use if blister unit is torn or open

Inactive Ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil,

purified water

May Contain: sorbitol special, titanium dioxide, white edible ink

Description

Simethicone 125mg

Principal Display Panel

Anti Gas

Use(s)

for the relief of

pressure, bloating, and fullness commonly referred to as gas

Storage

store at room temperature 20^o-25^oC (68^o-77^oF)
protect from light, heat and moisture

Active Ingredient(s)

Simethicone 125mg

Structured Label Content

Purpose

Anti gas

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 (Other information)

Do not use if blister unit is torn or open

Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil,

purified water

May Contain: sorbitol special, titanium dioxide, white edible ink

Principal Display Panel

Anti Gas

Use(s)

for the relief of

pressure, bloating, and fullness commonly referred to as gas

Storage

store at room temperature 20^o-25^oC (68^o-77^oF)
protect from light, heat and moisture

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

Simethicone 125mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "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": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "for the relief of pressure, bloating, and fullness commonly referred to as gas ", "Purpose": "Anti gas", "Storage": "store at room temperature 20 o -25 o C (68 o -77 o F) protect from light, heat and moisture", "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": "Do not use if blister unit is torn or open ", "Active ingredient(s)": "Simethicone 125mg", "Inactive ingredients": "D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water May Contain : sorbitol special, titanium dioxide, white edible ink", "Principal Display Panel": "Anti Gas"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:25.958184 · Updated: 2026-03-14T23:01:24.251815