Active Ingredient (In Each Capsule)
Simethicone 125 mg
Simethicone Capsule, Liquid Filled
FDA Label NDC 53345-009
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 Simethicone (NDC 53345-009). 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 for relief of:, 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
Purpose
Antiflatulent
Uses For Relief Of:
- bloating
- pressure
- fullness
- stuffed feeling commonly referred to as gas
Warnings
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime
- do not exceed 4 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
D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
SIMETHICONE CAPSULES, 125 mg
Quantity : 25000 Capsules
NDC. No : 53345-009-01
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.
