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Product NDC Code | 63868-108 | ||||
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Drug Name | Qc gas relief mint flavor |
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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 | 314216 | ||||
Application Number | M002 | ||||
Labeler Name | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Simethicone 80 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 ▪ thoroughly chew 1 to 2 tablets as needed after meals and at bedtime ▪ do not exceed 6 tablets per day unless directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients dextrose, peppermint flavor, maltodextrin, microcrystalline cellulose, silica, 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: ▪ bloating ▪ pressure ▪ fullness ▪ stuffed feeling
Purpose
Information about the drug product’s indications for use.Purpose Antigas
Spl product data elements
Usually a list of ingredients in a drug product.QC Gas Relief Mint Flavor Simethicone DIMETHICONE DIMETHICONE DEXTROSE, UNSPECIFIED FORM PEPPERMINT MALTODEXTRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE TRICALCIUM PHOSPHATE RP108
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 63868-108-01 QUALITY CHOICE ® *Compare to the Mylanta ® Gas Active Ingredient Gas Relief Anti Gas Simethicone 80 mg Relieves: Pressure Bloating & Discomfort Mint Flavor 100 CHEWABLE TABLETS QC SATISFACTION GURANTEED Distributed by C.D.M.A., Inc. 43157 W. Nine Mile Novi, MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300 This product is not manufactured or distributed by JOHNSON & JOHNSON MERCK Consumer Pharmaceuticals Co., the distributed of MYLANTA ® GAS Quality Choice Simethicone 100 Chewable Tablets QC(CDMA) Simethicone Mint Flavor 100 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 ▪ store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF) ▪ do not use if inner seal is broken or missing ▪ each tablets contains: calcium 60mg
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. In case of overdose, get medical help or contact a Poison Control Center immediately.
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