Active Ingredient (In Each Tablet)
Simethicone 125 mg
Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 0363-0119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Extra Strength Gas Relief (NDC 0363-0119). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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. |
Extra Strength Gas Relief 18 Chewable Tablets (134ppt)
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