Simethicone
FDA Label NDC 48769-113

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 48769-113). 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 (per soft gel), purpose, uses, warnings, directions, other information, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Soft Gel)

Simethicone 125 mg

Purpose

Antigas

Uses

Relieves pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

Directions

  • Do not exceed 4 softgels in 24 hours
  • Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime

Other Information

store at 200 - 250C

Inactive Ingredients

D and C yellow 10, FD and C blue 1, FD and C red 40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

Package Label.Principal Display Panel

Simethicone Capsules 125 mg Label (Mm1)

Simethicone Capsules 125 mg Label (Mm1)

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children

* Please review the disclaimer below.