certified plus anti-gas simethicone 180 mg

SPL v2

SPL

SPL Set ID d087743f-b82f-2a5c-e053-2995a90abb20

Route

oral

Published

Effective Date 2018-12-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (180 mg)

Inactive Ingredients

water gelatin fd&c yellow no. 6 sorbitol glycerin

Identifiers & Packaging

Pill Appearance

Imprint: PC3 Shape: oval Color: orange Size: 3 mm

Marketing Status

otc monograph drug active Since 2021-11-11

Purpose

Antiflatulent

Description

Simethicone 180 mg

Medication Information

Warnings

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

Uses

relieves

bloating
pressure
fullness commonly referred to as gas

Purpose

Antiflatulent

Directions

swallow 1 to 2 softgels as needed after meals and at bed time.
do not exceed 6 tablets per day unless directed by a physician

Other Information

store at room temperature 15-30 °C (59-86 °F)
protect from moisture

Inactive Ingredients

FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol

Description

Simethicone 180 mg

Section 50565-1

Keep out of reach of children

Package Label

Active Ingredient

Simethicone 180 mg

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Structured Label Content

Warnings

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

Uses

relieves

bloating
pressure
fullness commonly referred to as gas

Purpose

Antiflatulent

Directions

swallow 1 to 2 softgels as needed after meals and at bed time.
do not exceed 6 tablets per day unless directed by a physician

Other Information

store at room temperature 15-30 °C (59-86 °F)
protect from moisture

Inactive Ingredients

FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol

Section 50565-1 (50565-1)

Keep out of reach of children

Package Label

Active Ingredient

Simethicone 180 mg

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "180", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating pressure fullness commonly referred to as gas", "50565-1": "Keep out of reach of children", "Purpose": "Antiflatulent", "Warnings": "If pregnant or breast-feeding, ask a health professional before use.", "Directions": "swallow 1 to 2 softgels as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician", "Active Ingredient": "Simethicone 180 mg", "Other Information": "store at room temperature 15-30 °C (59-86 °F) protect from moisture", "Inactive Ingredients": "FD&C Yellow #6, gelatin, glycerin, purified water, sorbitol", "Questions or Comments": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:06.844658 · Updated: 2026-03-14T23:06:25.914429