FDA Label for Gas Relief
View Indications, Usage & Precautions
Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Llc. 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.
Drug Facts
Active Ingredient (In Each Softgel)
Simethicone 250 mg
Purpose
Antigas
Use
for the relief of pressure, bloating, and fullness, commonly referred to as gas.
Otc - Ask Doctor
Stop use and ask a doctor if condition persists
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding,ask a health professional before use.
Keep out of reach of children.
Directions
- adults and children 12 years and older:swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Other Information
- store at 20° to 25°C (68° to 77°F)
- protect from light, heat and moisture
- DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
Inactive Ingredients
D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.
Questions?
call 1-800-630-8895
Other
Distributed by:
Advanced Rx LLC
1942 NE 163rd St North Miami Beach,
FL 33162 U.S.A.
Package Label.Principal Display Panel
NDC 80513-112-01
Compare to the active ingredient in Maximum Strength Gas-X ®†
HIGH POTENCY
GAS RELIEF
Simethicone 250 mg
• RELIEVES GAS FAST
• PRESSURE
• BLOATING
• DISCOMFORT
100 SOFTGELS
†This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ®
* Please review the disclaimer below.
