simethicone 80 mg chewable tablets

SPL v3

SPL

SPL Set ID 5e755184-0821-4f92-8f72-84726f7aa407

Route

oral

Published

Effective Date 2025-12-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone, unspecified (80 mg)

Inactive Ingredients

dextrose, unspecified form magnesium stearate maltodextrin microcrystalline cellulose silicon dioxide tribasic calcium phosphate

Identifiers & Packaging

Pill Appearance

Imprint: RP111 Shape: round Color: white Size: 15 mm Score: 2

Marketing Status

otc monograph drug active Since 2024-10-01

Purpose

ANTI-GAS

Description

SIMETHICONE 80MG

Medication Information

Warnings

•
GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.

Active Ingredient

SIMETHICONE 80MG

Uses

•
RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT

Purpose

ANTI-GAS

Directions

•
ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE.
•
DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.

Other Information

•
EACH TABLET CONTAINS: CALCIUM 60MG
•
STORE AT ROOM TEMPERATURE

Inactive Ingredients

DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE

Description

SIMETHICONE 80MG

Principal Display Panel

NDC 55154-2606-0

SIMETHICONE 80mg

CHEWABLE TABLETS

10 CHEWABLE TABLETS

Overbagged with 10 chewable tablets per bag, NDC 55154-2606-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L58749201125

LB81210X09

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Structured Label Content

Warnings (WARNINGS)

•
GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.

Active Ingredient (ACTIVE INGREDIENT (IN EACH TABLET))

SIMETHICONE 80MG

Uses (USES)

•
RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT

Purpose (PURPOSE)

ANTI-GAS

Directions (DIRECTIONS)

•
ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE.
•
DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.

Other Information (OTHER INFORMATION)

•
EACH TABLET CONTAINS: CALCIUM 60MG
•
STORE AT ROOM TEMPERATURE

Inactive Ingredients (INACTIVE INGREDIENTS)

DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE

Principal Display Panel

NDC 55154-2606-0

SIMETHICONE 80mg

CHEWABLE TABLETS

10 CHEWABLE TABLETS

Overbagged with 10 chewable tablets per bag, NDC 55154-2606-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L58749201125

LB81210X09

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Advanced Ingredient Data

[{"name": "DIMETHICONE, UNSPECIFIED", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{".": "Overbagged with 10 chewable tablets per bag, NDC 55154-2606-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L58749201125 LB81210X09", "USES": "• RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT", "50565-1": "KEEP OUT OF REACH OF CHILDREN.", "PURPOSE": "ANTI-GAS", "WARNINGS": "• GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY AT 1-800-222-1222.", "DIRECTIONS": "• ADULTS CHEW 1 OR 2 TABLETS COMPLETELY AS NEEDED AFTER MEALS AND AT BEDTIME. DO NOT SWALLOW TABLETS WHOLE. • DO NOT EXCEED 6 TABLETS IN 24 HOUR PERIOD EXCEPT UNDER THE ADVICE AND SUPERVISION OF A PHYSICIAN.", "OTHER INFORMATION": "• EACH TABLET CONTAINS: CALCIUM 60MG • STORE AT ROOM TEMPERATURE", "INACTIVE INGREDIENTS": "DEXTROSE, FLAVOR, MAGNESIUM STEARATE, MALTODEXTRIN, MICROCRYSTALLINE CELLULOSE, SILICA, TRIBASIC CALCIUM PHOSPHATE", "Principal Display Panel": "NDC 55154-2606-0 SIMETHICONE 80mg CHEWABLE TABLETS 10 CHEWABLE TABLETS", "ACTIVE INGREDIENT (IN EACH TABLET)": "SIMETHICONE 80MG"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:39.295555 · Updated: 2026-03-14T23:11:33.591824