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| Product NDC Code | 21130-441 | ||||
|---|---|---|---|---|---|
| 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 | SAFEWAY | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 and Childrens 12 years and older: chew 1 to 2 tablets thoroughly 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 red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose
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.USE(S) relieves: • Pressure, bloating and fullness 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, UNSPECIFIED DIMETHICONE D&C YELLOW NO. 10 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE SUCRALOSE 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 *Compare to the active ingredient in Gas-X Extra Strength NDC 21130-441-48 Extra strength Gas Relief Simethicone 125 mg/Anti-Gas Fast Relief of Pressure, Bloating & Discomfort Peppermint Flavor Naturally and Artificially Flavored 18 Chewable Tablets *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength. 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 In case of overdose, get medical help or contact a poison control center immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other Information ▪ each tablet contains: calcium 45 mg ▪ store at room temperature ▪ protect from moisture
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