FDA Label for Gas Relief Ultra Strength
View Indications, Usage & Precautions
Gas Relief Ultra Strength 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 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.