FDA Label for Publix Extra Strength
View Indications, Usage & Precautions
Publix Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets, Inc. 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 Softgel)
Simethicone 125 mg
Purpose
Antigas
Uses
for relief of:
▪ pressure, bloating and fullness commonly referred to as gas
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▪ protect from light, heat and moisture.
Inactive Ingredients
D&C yellow No. 10, FD&C blue No. 1, FD&C red No. 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC 41415-113-30
*Compare to the active ingredient Gas-X® Extra Strength
Extra Strength
Gas Relief
SIMETHICONE 125 MG/ANTI-GAS
Relieves:
• Discomfort• Pressure• Bloating
30 SOFTGELS
IMPORTANT: Keep this carton for future reference on full labeling.
DISTRIBUTED BY: PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
1-888-267-3037 publix.com
PUBLIX GUARANTEE:
COMPLETE SATISFACTION OR YOUR MONEY BACK
*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra Strength.
DO NOT USE IF ANY INDIVIDUAL BLISTERS UNIT IS BROKEN OR OPEN.
* Please review the disclaimer below.