Sunmark Gas Relief

SPL v1

SPL

SPL Set ID 3fc6ab63-42cf-4fc6-8e98-d3fe1082ad62

Route

ORAL

Published

Effective Date 2014-04-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone (80 mg)

Inactive Ingredients

Raw Sugar Dextrose Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: GDC156 Shape: round Color: white Size: 14 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2004-04-10

Description

Simethicone 80 mg

Purpose

Anti-gas

Medication Information

Purpose

Anti-gas

Description

Simethicone 80 mg

Uses

relieves

pressure
bloating
symptoms referred to as gas

Section 50565-1

Warnings

Keep out of 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 6 tablets per day unless directed by 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 40°C (104°F)

Inactive Ingredients

compressible sugar, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

Principal Display Panel

Sunmark

COMPARE TO GAS-X^® ACTIVE INGREDIENT

gas relief

Regular Strength

Fast relief of pressure, bloating & discomfort of gas

SIMETHICONE 80 mg

Peppermint creme

36 Chewable Tablets

Active Ingredient (in Each Tablet)

Simethicone 80 mg

Structured Label Content

Uses

relieves

pressure
bloating
symptoms referred to as gas

Section 50565-1 (50565-1)

Purpose

Anti-gas

Warnings

Keep out of 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 6 tablets per day unless directed by 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 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

compressible sugar, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

Principal Display Panel

Sunmark

COMPARE TO GAS-X^® ACTIVE INGREDIENT

gas relief

Regular Strength

Fast relief of pressure, bloating & discomfort of gas

SIMETHICONE 80 mg

Peppermint creme

36 Chewable Tablets

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

Simethicone 80 mg

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "RAW SUGAR", "unii": "8M707QY5GH", "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)

{"Uses": "relieves pressure bloating symptoms referred to as gas", "Purpose": "Anti-gas", "Warnings": "Keep out of 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 6 tablets per day unless directed by 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 40°C (104°F)", "Inactive ingredients": "compressible sugar, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol", "Principal Display Panel": "Sunmark COMPARE TO GAS-X ® ACTIVE INGREDIENT gas relief Regular Strength Fast relief of pressure, bloating & discomfort of gas SIMETHICONE 80 mg Peppermint creme 36 Chewable Tablets", "Active ingredient (in each tablet)": "Simethicone 80 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:47.092192 · Updated: 2026-03-14T22:53:43.600487