Gendose - Simethicone 80 Mg Chewable Tablets (77333-812)

Gendose - Simethicone 80 Mg Chewable Tablets (77333-812)
SPL v6
SPL
SPL Set ID e7f470cf-f036-afd9-e053-2995a90a9186
Route
ORAL
Published
Effective Date 2022-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (80 mg)
Inactive Ingredients
Magnesium Stearate Dextrose Maltodextrin Tribasic Calcium Phosphate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RP111 Shape: round Color: white Size: 15 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-02
Description

SIMETHICONE 80MG

Purpose

ANTI-GAS

Medication Information

Purpose

ANTI-GAS

Description

SIMETHICONE 80MG

Uses
  • RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT
Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

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

Active Ingredient (in Each Tablet)

SIMETHICONE 80MG

Structured Label Content

Uses (USES)
  • RELIEVES GAS DISTRESS, BLOATING, AND DISCOMFORT
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTI-GAS

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

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

SIMETHICONE 80MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.662974 · Updated: 2026-03-14T23:02:54.359020