Extra Strength Gas Relief Peppermint Tablets

SPL v1

SPL

SPL Set ID 14a9fb00-707a-4b55-a060-82ad53a806e3

Route

ORAL

Published

Effective Date 2016-01-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (125 mg)

Inactive Ingredients

D&c Red No. 30 D&c Yellow No. 10 Dextrose Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-11-11

Description

Simethicone 125 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 125 mg

Pdp

*Compare to GAS-X®E-X Chewable active ingredient

Signature Care

Extra strength Gas Relief

Simethicone 125 mg

Anti-Gas

Peppermint Flavor

Relieves symptoms of gas discomfort, pressure and bloating

18 chewable tablets

Uses

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other Information

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40oC (104oF)

Inactive Ingredients

D&C red 30 aluminum lake, D&C yellow 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Active Ingredient (in Each Tablet)

Simethicone 125 mg

Structured Label Content

Pdp (PDP)

*Compare to GAS-X®E-X Chewable active ingredient

Signature Care

Extra strength Gas Relief

Simethicone 125 mg

Anti-Gas

Peppermint Flavor

Relieves symptoms of gas discomfort, pressure and bloating

18 chewable tablets

Uses

relieves:

pressure
bloating
symptoms referred to as gas

Purpose

Anti-gas

Warnings

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other Information (Other information)

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40oC (104oF)

Inactive Ingredients (Inactive ingredients)

D&C red 30 aluminum lake, D&C yellow 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Simethicone 125 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "125", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PDP": "*Compare to GAS-X®E-X Chewable active ingredient Signature Care Extra strength Gas Relief Simethicone 125 mg Anti-Gas Peppermint Flavor Relieves symptoms of gas discomfort, pressure and bloating 18 chewable tablets", "Uses": "relieves: pressure bloating symptoms referred to as gas", "Purpose": "Anti-gas", "Warnings": "Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.", "Directions": "chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician", "Other information": "do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40oC (104oF)", "Inactive ingredients": "D&C red 30 aluminum lake, D&C yellow 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose", "Active ingredient (in each tablet)": "Simethicone 125 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:03.658275 · Updated: 2026-03-14T22:54:14.381059