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
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

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51945-4 (51945-4)

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