Simethicone Capsule, Liquid Filled
FDA Label NDC 53345-036

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 53345-036). 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, 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 180 mg

Purpose

Anti-gas

Uses

  • relieves bloating, pressure or fullness commonly referred to as gas

Directions

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

Other Information

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

Inactive Ingredients

FD&C yellow#6, gelatin, glycerin, purified water and white edible ink

Principal Display Panel - Shipping Label

SIMETHICONE CAPSULES, 180 mg

Quantity : 25000 Capsules
NDC. No : 53345-036-01

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

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