Gas Relief Simethicone 125 Mg

SPL v4

SPL

SPL Set ID e11928e8-b9db-43c5-972b-33b325090dfc

Route

ORAL

Published

Effective Date 2018-12-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

Dextrose Sucrose Microcrystalline Cellulose Maltodextrin Peppermint Silicon Dioxide Sorbitol Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: AP;040 Shape: round Color: white Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-11-01

Description

(in each chewable tablet) Simethicone 125 mg

Purpose

Antiflatulent

Medication Information

Purpose

Antiflatulent

Description

(in each chewable tablet) Simethicone 125 mg

Uses

relieves

bloating
pressure
discomfort of gas which can be caused by certain foods or air swallowing

Section 50565-1

Keep out of reach of children

Warnings

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

Directions

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

Package Label

NDC: 17714-040-60 – 60 CHEWABLE TABLETS

Active Ingredient

(in each chewable tablet)

Simethicone 125 mg

Other Information

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

Inactive Ingredients

dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

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

Uses

relieves

bloating
pressure
discomfort of gas which can be caused by certain foods or air swallowing

Section 50565-1 (50565-1)

Keep out of reach of children

Purpose

Antiflatulent

Warnings

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

Directions

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

Package Label

NDC: 17714-040-60 – 60 CHEWABLE TABLETS

Active Ingredient

(in each chewable tablet)

Simethicone 125 mg

Other Information

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

Inactive Ingredients

dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

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": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEPPERMINT", "unii": "V95R5KMY2B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing", "50565-1": "Keep out of reach of children", "Purpose": "Antiflatulent", "Warnings": "If pregnant or breast-feeding, ask a health professional before use.", "Directions": "chew thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician", "Package Label": "NDC: 17714-040-60 – 60 CHEWABLE TABLETS", "Active Ingredient": "(in each chewable tablet) Simethicone 125 mg", "Other Information": "store at room temperature 15-30 °C (59-86 °F) protect from moisture", "Inactive Ingredients": "dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid", "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: 2026-02-15T11:56:42.595723 · Updated: 2026-03-14T22:55:22.018235