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| Product NDC Code | 0363-0119 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength gas relief |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 314221 | ||||
| Application Number | M002 | ||||
| Labeler Name | WALGREENS CO. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Simethicone 125 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients D&C yellow # 10 lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sucralose, tribasic calcium phosphate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves pressure and bloating commonly referred to as gas
Purpose
Information about the drug product’s indications for use.Purpose Anti-gas
Spl product data elements
Usually a list of ingredients in a drug product.Extra Strength Gas Relief Simethicone Antigas DIMETHICONE DIMETHICONE D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SUCRALOSE SILICON DIOXIDE TRIBASIC CALCIUM PHOSPHATE RP110
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children
Storage and handling
Information about safe storage and handling of the drug product.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
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API