FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Capsule)
Simethicone 125 mg
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.
