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 125 mg
Purpose
Antigas
Uses
for relief of
- pressure, bloating, and fullness commonly referred to as gas
Warnings
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
- store at room temperature 15°-30°C (59°-86°F)
- protect from light, heat and moisture
Inactive Ingredients
D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, 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, 125 mg
Quantity : 25000 Capsules
NDC. No : 53345-033-01
IMPORTANT:
- Inspect immediate upon receipt.
- This is a bulk shipment, intended for further processing only.
- Protect from heat, humidity, and light. Do not refrigerate.
- Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
* Please review the disclaimer below.
