419- anti gas

SPL v6

SPL

SPL Set ID 7731bd63-667e-4fed-b446-92a4a83b66d6

Route

oral

Published

Effective Date 2020-11-03

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 and children 12 years and older: 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
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Description

Simethicone 125mg

Principal Display Panel

Gas Relief

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

Questions

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

Active Ingredient(s)

Simethicone 125mg

Structured Label Content

Purpose

Anti gas

Directions

adults and children 12 years and older: 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
do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

Principal Display Panel

Gas Relief

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

Questions

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

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": ""}]

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", "Questions": "Call 1-888-952-0050 Monday through Friday 9AM - 5PM", "Directions": "adults and children 12 years and older: 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 do not use if imprinted safety seal under cap is broken or missing", "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, white edible ink", "Principal Display Panel": "Gas Relief"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:37.575696 · Updated: 2026-03-14T23:05:29.389553