mi-acid gas relief

SPL v1

SPL

SPL Set ID 1ff12230-d8ec-432c-8162-b27c60aaed63

Route

oral

Published

Effective Date 2020-07-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (80 mg)

Inactive Ingredients

sucrose dextrose, unspecified form magnesium stearate maltodextrin cellulose, microcrystalline sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: GDC103 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

otc monograph final active Since 2011-03-02

Purpose

Antigas

Description

Simethicone 80 mg

Medication Information

Warnings

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

Active Ingredient

Simethicone 80 mg

Uses

relieves:

pressure
bloating
symptoms referred to as gas

Purpose

Antigas

Directions

chew 2 to 4 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 inner seal is broken.
store at room temperature
avoid high humidity and excessive heat, above 40⁰C (104⁰F)

Inactive Ingredients

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

Description

Simethicone 80 mg

Pdp

NDC 17856-5068-2

Mi-Acid Gas Relief

Relieves Gas Pain, Pressure and Bloating

Simethicone 80 mg/Antiflatulent

100 Chewable Tablets

Section 50565-1

Questions Or Comments?

Call (800) 616-2471

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Structured Label Content

Warnings

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

Active Ingredient (Active ingredient (in each tablet))

Simethicone 80 mg

Uses

relieves:

pressure
bloating
symptoms referred to as gas

Purpose

Antigas

Directions

chew 2 to 4 tablets thoroughly as needed after meals and at bedtime.
do not exceed 6 tablets per day unless directed by a physician.

Other Information (Other information)

do not use if inner seal is broken.
store at room temperature
avoid high humidity and excessive heat, above 40⁰C (104⁰F)

Inactive Ingredients (Inactive ingredients)

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

Pdp (PDP)

NDC 17856-5068-2

Mi-Acid Gas Relief

Relieves Gas Pain, Pressure and Bloating

Simethicone 80 mg/Antiflatulent

100 Chewable Tablets

Section 50565-1 (50565-1)

Questions Or Comments? (Questions or comments?)

Call (800) 616-2471

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Advanced Ingredient Data

[{"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "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": "NDC 17856-5068-2 Mi-Acid Gas Relief Relieves Gas Pain, Pressure and Bloating Simethicone 80 mg/Antiflatulent 100 Chewable Tablets", "Uses": "relieves: pressure bloating symptoms referred to as gas", "Purpose": "Antigas", "Warnings": "Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.", "Directions": "chew 2 to 4 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 inner seal is broken. store at room temperature avoid high humidity and excessive heat, above 40 0 C (104 0 F)", "Inactive ingredients": "compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol", "Questions or comments?": "Call (800) 616-2471 DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179", "Active ingredient (in each tablet)": "Simethicone 80 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:15.609186 · Updated: 2026-03-14T22:57:44.218849