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.
Other
Drug Facts
Active Ingredient (In Each Softgel)
Simethicone 250 mg
Purpose
Anti-gas
Use
relieves bloating, pressure or fullness commonly referred to as gas
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
D&C red # 33, FD&C blue # 1, gelatin, glycerin, purified water and white edible ink
Principal Display Panel - Shipping Label
Simethicone Capsules 250 mg
NDC 53345-032-02
Quantity: 12 Capsules per blister
124 Blisters per box
IMPORTANT:
- Inspect immediately upon receipt.
- This is a bulk shipment, intended for further processing only.
- Protect from heat, humidity, and light. Do not refrigerate.
- Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
* Please review the disclaimer below.
