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 Cardinal Health. 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
Each tablet contains 80 mg Simethicone
Mint Flavored chewable tablets
Purpose
Anti-gas
Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children.
Uses
Relieves pressure, bloating, and symptoms referred to as gas.
Warnings
This package is intended for institutional use only.
Do not exceed six tablets in a 24 hour period except under the advice and supervision of a physician.
In case of overdose get medical help or contact a Poison Control Center immediately.
Directions
Chew one or two tablets thoroughly as needed after meals and at bedtime.
Inactive Ingredients
Compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin and sorbitol.
Storage
STORE at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F).
Mint Flavored chewable Tablets
Sky
Mfg. By: Guardian Drug Company
2 Charles Court
Dayton, NJ 08810
Distributed By
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddington Road
Concord, NC 28027
Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids
www.PROmanager-Rx.com
Repackaged by Cardinal Health
Zanesville, OH 43701
L43456330115
Principal Display Panel
Simethicone Anti-Gas
80 mg Tablets
10 Tablets
* Please review the disclaimer below.