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 Shopko Stores Operating Co., 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.
Active Ingredient (In Each Softgel)
Simethicone 125 mg
Purpose
Antiflatulent
Uses
for relief of:
- bloating
- pressure
- fullness
- stuffed feeling commonly referred to as gas
Stop Use And Ask A Doctor If
condition persists.
If Pregnant Or Breast- Feeding
ask a health care professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor.
Other Information
- store at controlled room temperature 15o- 30o C (59o- 86o F)
- protect from heat and moisture
- *This product is not manufactured or distributed by Novartis Consumer Healthcare Inc., owner of the registered trademark Extra Strength Gas-X®.
Inactive Ingredients
D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special.
Principal Display Panel
Extra Strength Gas Relief
ANTIGAS
SIMETHICONE 125 mg
Relieves:
- bloating
- pressure
- fullness
- gas
*Compare to Extra Strength Gas-X® active ingredient
Packaged by: PL Developments
200 hicks street
westbury, NY 11590 USA
QUESTIONS OR COMMENTS?
call toll free 1-877-753-3935
EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.
Product Label
SIMETHICONE 125 MG
* Please review the disclaimer below.