Simethicone Capsule, Liquid Filled
FDA Label NDC 53345-033

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 53345-033). 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 capsule), purpose, uses, warnings, directions, other information, inactive ingredients, principal display panel - shipping label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Capsule)

Simethicone 125 mg

Purpose

Antigas

Uses

for relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warnings

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

  • store at room temperature 15°-30°C (59°-86°F)
  • protect from light, heat and moisture

Inactive Ingredients

D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China

Principal Display Panel - Shipping Label

SIMETHICONE CAPSULES, 125 mg

Quantity : 25000 Capsules
NDC. No : 53345-033-01

IMPORTANT:

  • Inspect immediate 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.