Simethicone Capsule, Liquid Filled
FDA Label NDC 53345-032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. for the product Simethicone (NDC 53345-032). 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 other, active ingredient (in each softgel), purpose, use, stop use and ask a doctor if, 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

Other

Drug Facts

Active Ingredient (In Each Softgel)

Simethicone 250 mg

Purpose

Anti-gas

Use

relieves bloating, pressure or fullness commonly referred to as gas

Stop Use And Ask A Doctor If

condition persists

Directions

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

  • store at room temperature 59°-86°F (15°-30°C)

Inactive Ingredients

D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink

Principal Display Panel - Shipping Label

Simethicone Capsules 250 mg

NDC 53345-032-02

Quantity: 12 Capsules per blister  

               124 Blisters per box

IMPORTANT:

  • Inspect immediately upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)

    • CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

* Please review the disclaimer below.