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) Co., 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 250 mg
Purpose
Anti-gas
Uses
- relieves bloating, pressure or fullness commonly referred to as gas
Warnings
Stop Use And Ask A Doctor If
condition persists
Directions
- swallow one or two softgels after a meal
- do not exceed two softgels per 24 hours 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 Blue #1, FD&C Red #40, gelatin, glycerin, purified water, and white edible ink
Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China
Principal Display Panel - Shipping Label
SIMETHICONE CAPSULES, 250 mg
Quantity : 25000 Capsules
NDC. No : 53345-032-01
IMPORTANT:
1.Inspect immediate upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
* Please review the disclaimer below.
