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| Product NDC Code | 0132-0208 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Phazyme |
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| Type | Brand | ||||||
| Pharm Class | Skin Barrier Activity [PE] | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE, GELATIN COATED | ||||||
| RxCUI drug identifier | 252294, 352091 |
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| Application Number | part332 | ||||||
| Labeler Name | C.B. Fleet Company, Inc. | ||||||
| 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 fast gel) Simethicone 180mg
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 Swallow one or two fast gels as symptoms occur Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive In g redients FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, purified water
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 Relieves bloating, pressure or 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.PHAZYME Simethicone DIMETHICONE DIMETHICONE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN WATER PZ;180
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 PHAZYME® ULTRA STRENGTH ANTI-GAS SIMETHICONE 180 MG 12 fast gels PHAZYME® ULTRA STRENGTH ANTI-GAS SIMETHICONE 180 MG 12 fast gels
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 .
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature 59°-86°F (15°-30°C).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free 1-855-727-4277 TAMPER EVIDENT PACKAGE Do not use if blister or printed foil is broken or torn, or if “PZ180” is missing from Fast Gel.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition persists.
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 Stop use and ask a doctor if condition persists. 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