yet - bare & better anti-gas simethicone - simethicone 250 mg

SPL v7

SPL

SPL Set ID 774f50a8-9584-499b-aaf5-39dd9bc2a5b4

Route

oral

Published

Effective Date 2021-08-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (250 mg)

Inactive Ingredients

fd&c blue no. 1 d&c red no. 33 gelatin glycerin povidone water sorbitol sorbitan titanium dioxide

Identifiers & Packaging

Pill Appearance

Imprint: IS9 Shape: oval Color: purple Size: 12 mm Score: 1

Marketing Status

otc monograph drug active Since 2021-08-11

Purpose

Antigas

Description

Simethicone 250 mg

Medication Information

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Uses

for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Purpose

Antigas

Directions

adults and children 12 years and older: swallow with wa ter 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the ad vi ce and supervision of a physici an

Other Information

■ store at 20° to 25°C (68° to 77°F)

■ protect from light, heat and moisture

Inactive Ingredients

D&C blue #1, D&C Red # 33, gelatin, glycerin, povidone, puriﬁed water, sorbitol, sorbitan, titanium dioxide.

Description

Simethicone 250 mg

Questions?

call 1-844-735-0202

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredient

Simethicone 250 mg

Structured Label Content

Warnings

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

Uses

for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Purpose

Antigas

Directions

adults and children 12 years and older: swallow with wa ter 1 or 2 softgels as needed after meals and at bedtime
do not exceed 2 softgels in 24 hours except under the ad vi ce and supervision of a physici an

Other Information (Other information)

■ store at 20° to 25°C (68° to 77°F)

■ protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

D&C blue #1, D&C Red # 33, gelatin, glycerin, povidone, puriﬁed water, sorbitol, sorbitan, titanium dioxide.

Questions?

call 1-844-735-0202

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Simethicone 250 mg

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "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": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the relief of pressure, bloating, and fullness, commonly referred to as gas.", "50565-1": "Keep out of reach of children.", "Purpose": "Antigas", "Warnings": "Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health professional before use.", "Directions": "adults and children 12 years and older: swallow with wa ter 1 or 2 softgels as needed after meals and at bedtime do not exceed 2 softgels in 24 hours except under the ad vi ce and supervision of a physici an", "Questions?": "call 1-844-735-0202", "Active ingredient": "Simethicone 250 mg", "Other information": "■ store at 20° to 25°C (68° to 77°F) ■ protect from light, heat and moisture", "Inactive ingredients": "D&C blue #1, D&C Red # 33, gelatin, glycerin, povidone, puriﬁed water, sorbitol, sorbitan, titanium dioxide."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.878927 · Updated: 2026-03-14T23:02:19.584479