Gas Relief Ultra Strength Capsule, Liquid Filled
FDA Label NDC 53345-003

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), Ltd. for the product Gas Relief Ultra Strength (NDC 53345-003). 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, usesfor relief of:, 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 Capsule)

Simethicone 180 mg

Purpose

Antiflatulent

Usesfor Relief Of:

  • bloating
  • pressure
  • fullness
  • stuffed feeling commonly referred to as gas

Warnings

Stop use and ask a doctor if condition persists.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • swallow 1 or 2 softgels as needed after meals
  • do not exceed 2 softgels per day unless directed by doctor

Other Information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

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

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

Principal Display Panel - Shipping Label

SIMETHICONE CAPSULES,180 mg

Quantity : 25000 Capsules
NDC. No : 53345-003-03

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

* Please review the disclaimer below.