Gas Relief Ultra Strength
Simethicone
Preferred Pharmaceuticals Inc.
Human Otc Drug
NDC 68788-7890Gas Relief Ultra Strength also known as Simethicone is a human otc drug labeled by 'Preferred Pharmaceuticals Inc.'. National Drug Code (NDC) number for Gas Relief Ultra Strength is 68788-7890. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Gas Relief Ultra Strength drug includes Dimethicone - 180 mg/1 . The currest status of Gas Relief Ultra Strength drug is Active.
Drug Information:
| Drug NDC: | 68788-7890 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Gas Relief Ultra Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Gas Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Ultra Strength |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Simethicone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Preferred Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMETHICONE - 180 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 23 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part332 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Preferred Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 252294
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| NUI: | N0000010282
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 92RU3N3Y1O
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class PE: | Skin Barrier Activity [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Skin Barrier Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68788-7890-3 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68788-7890-3) | 23 Apr, 2021 | N/A | No |
| 68788-7890-6 | 36 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68788-7890-6) | 23 Apr, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antigas
Product Elements:
Gas relief ultra strength simethicone dimethicone dimethicone fd&c yellow no. 6 gelatin, unspecified glycerin fd&c red no. 40 05a
Indications and Usage:
Uses relieves bloating, pressure, or fullness commonly referred to as gas
Warnings:
Warnings stop use and ask a doctor if condition persists. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children.
Dosage and Administration:
Directions swallow one or two softgels as symptoms occur do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Stop Use:
Stop use and ask a doctor if condition persists.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredient in phazyme® ultra strength ultra strength simethicone 180 mg antigas fast relief of gas pressure bloating discomfort this product is not manufactured or distributed by c.b. fleet company inc., distributor of phazyme® ultra strength tamper evident: do not use if printed safety seal under cap is broken or missing distributed by: rugby® laboratories 17177 n laurel park drive, suite 233 livonia, mi 48152 error! hyperlink reference not valid. .
Product label rugby laboratories ultra strength simethicone simethicone softgels 180mg
Further Questions:
Questions or comments? call 1-800-645-2158