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

Purpose

Antiflatulent

Description

(in each chewable tablet) Simethicone 125 mg

Medication Information

Warnings

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

Uses

relieves

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

Purpose

Antiflatulent

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

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

Description

(in each chewable tablet) Simethicone 125 mg

Section 50565-1

Keep out of reach of children

Package Label

NDC: 17714-040-60 – 60 CHEWABLE TABLETS

Active Ingredient

(in each chewable tablet)

Simethicone 125 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
discomfort of gas which can be caused by certain foods or air swallowing

Purpose

Antiflatulent

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

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

Section 50565-1 (50565-1)

Keep out of reach of children

Package Label

NDC: 17714-040-60 – 60 CHEWABLE TABLETS

Active Ingredient

(in each chewable tablet)

Simethicone 125 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": "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:42.595723 · Updated: 2026-03-14T22:55:22.018235