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 Walgreens Co.. 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
Uses
relieves pressure and bloating commonly referred to as gas
Directions
▪ adults: chew 1 to 2 tablets 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 controlled room temperature 20-25°C (68-77°F)▪ protect from moisture▪ do not use if any individual blister unit is broken or open
Inactive Ingredients
D&C yellow # 10 lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sucralose, tribasic calcium phosphate
Principal Display Panel
WALGREENS PHARMACIST RECOMMENDED‡
NDC 0363-0119-18
EXTRA STRENGTH
Gas Relief
Simethicone 125 mg/Anti-Gas
For fast Relief of:
• Pressure• Bloating• Gas distress
PEPPERMINT CRÈME FLAVOR
18 Chewable Tablets
Compare to Extra Strength Gas-X® active ingredient‡‡
‡‡This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Gas-X®.
IMPORTANT: Keep this carton for future reference on full labeling. |
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