FDA Label for Gas Relief Extra Strength
View Indications, Usage & Precautions
Gas Relief Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Bjwc (berkley & Jensen / Bj's). 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 (Antigas)
Use
- relieves bloating, pressure, or fullness 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 and at bedtime.
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.
Other Information
- store at controlled room temperature 15°-30°C (59°-86°F)
- protect from heat and moisture
Inactive Ingredients
D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special and titanium dioxide.
Questions Or Comments?
call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST
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Compare to the active ingredient in Extra Strength Gas-X®*
Extra Strength
Gas Relief
Simethicone, 125 mg
Relieves:
- bloating
- fullness
- pressure
- gas
*This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas-X®
DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Product Label
Simethicone 125 mg
* Please review the disclaimer below.