FDA Label for Extra Strength Gas Relief
View Indications, Usage & Precautions
Extra Strength Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Safeway. 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 Tablet)
Simethicone 125 mg
Purpose
Anti-gas
Use(S)
relieves:
• Pressure, bloating and fullness commonly referred to as gas
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a poison control center immediately.
Directions
▪ adults and Childrens 12 years and older: chew 1 to 2 tablets thoroughly as needed after meals and at bedtime▪ do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician
Other Information
▪ each tablet contains: calcium 45 mg▪ store at room temperature▪ protect from moisture
Inactive Ingredients
D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose
Principal Display Panel
*Compare to the active ingredient in Gas-X Extra Strength
NDC 21130-441-48
Extra strength
Gas Relief
Simethicone 125 mg/Anti-Gas
Fast Relief of Pressure, Bloating & Discomfort
Peppermint Flavor
Naturally and Artificially Flavored
18 Chewable Tablets
*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength.
IMPORTANT: Keep this carton for future reference on full labeling. |
* Please review the disclaimer below.