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| Product NDC Code | 36800-488 | ||||
|---|---|---|---|---|---|
| Drug Name | Topcare extra strength gas relief cherry creme |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| Application Number | M002 | ||||
| Labeler Name | TOPCO ASSOCIATES LLC | ||||
| 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: chew 1 to 2 tablets as needed after meals and at bedtime ▪ do not exceed 4 tablets in 24 hour 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 No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, 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 Foe the relief of ▪ 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.TopCare Extra Strength Gas Relief Cherry Creme Simethicone DIMETHICONE, UNSPECIFIED DIMETHICONE D&C RED NO. 30 DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE SUCRALOSE TRIBASIC CALCIUM PHOSPHATE RP110 Cherry Creme
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 NDC 36800-488-48 COMPARE TO GAS-X® E XTRA STRENGTH ACTIVE INGREDIENT* EXTRA STRENGTH Gas Relief ANTIGAS/SIMETHICONE 125 mg FOR FAST RELIEF OF • Bloating • Pressure • Discomfort of Gas CHERRY CREME FLAVOR Naturally and Artificially Flavored 48 CHEWABLE TABLETS DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING DISTRIBUTED BY: TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 © TOPCO RARA1217 QUESTIONS? 1-888-423-0139 [email protected] , www.topcarebrand.com *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of GAS-X® Extra Strength. TopCare Extra Strength Simethicone 48 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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-467-2748
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 excessive heat and 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 Keep Out of Reach of Children
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