Simethicone
FDA Label NDC 48769-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Softech Pharma Pvt. Ltd. for the product Simethicone (NDC 48769-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Simethicone 180 mg

Purpose

Antigas

Uses

Relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask doctor if condition persists

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children

Directions

  • Swallow one or two softgels as needed after a meal
  • Do not exceed two softgels per day except under the advise and supervision of a physician

Other Information

  • Each softgel contains: potassium 5 mg
  • Store at 200 - 250C

Inactive Ingredients:

FD and C Red No. 40, FD and C yellow No. 6, Gelatin, Glycerol

Package Label.Principal Display Panel

Carton Label For 180 mg (Mm2)

Carton Label For 180 mg (Mm2)

* Please review the disclaimer below.