Simethicone 250mg

SPL v2

SPL

SPL Set ID fcc2ef8b-9181-2c59-e053-6394a90adcc1

Route

ORAL

Published

Effective Date 2022-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (250 mg)

Inactive Ingredients

Fd&c Blue No. 1 Gelatin Fd&c Red No. 40 Glycerin Water

Identifiers & Packaging

Pill Appearance

Imprint: PC31 Shape: oval Color: purple Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-12-01

Description

Simethicone 180mg

Medication Information

Indications and Usage

Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

Dosage and Administration

▪ 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

Description

Simethicone 180mg

Section 50565-1

Keep out of reach of children

Section 50566-9

stop use and ask a doctor if condition persists

Section 51727-6

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

Section 51945-4

Section 53414-9

if pregnant or breast-feedingm ask a health professional before use

Section 55105-1

relieves bloating, pressure, fullness, commonly referred to as gas

Section 55106-9

Simethicone 180mg

Structured Label Content

Indications and Usage (34067-9)

Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas

Dosage and Administration (34068-7)

▪ 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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

stop use and ask a doctor if condition persists

Section 51727-6 (51727-6)

FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

if pregnant or breast-feedingm ask a health professional before use

Section 55105-1 (55105-1)

relieves bloating, pressure, fullness, commonly referred to as gas

Section 55106-9 (55106-9)

Simethicone 180mg

Advanced Ingredient Data

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses relieves ▪ bloating ▪ pressure ▪ fullness commonly referred to as gas", "34068-7": "▪ 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", "50565-1": "Keep out of reach of children", "50566-9": "stop use and ask a doctor if condition persists", "51727-6": "FD&C Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink", "53414-9": "if pregnant or breast-feedingm ask a health professional before use", "55105-1": "relieves bloating, pressure, fullness, commonly referred to as gas", "55106-9": "Simethicone 180mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:17.195965 · Updated: 2026-03-14T23:06:51.816479