Extra Strength Gas Relief
Simethicone
Raritan Pharmaceuticals Inc
Human Otc Drug
NDC 68163-700Extra Strength Gas Relief also known as Simethicone is a human otc drug labeled by 'Raritan Pharmaceuticals Inc'. National Drug Code (NDC) number for Extra Strength Gas Relief is 68163-700. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Extra Strength Gas Relief drug includes Dimethicone - 125 mg/5mL . The currest status of Extra Strength Gas Relief drug is Active.
Drug Information:
| Drug NDC: | 68163-700 |
| 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: | Extra Strength Gas Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Extra Strength |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | gas relief |
| 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: | Raritan Pharmaceuticals Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 125 mg/5mL
|
| 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: | 26 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| 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: | Raritan Pharmaceuticals Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2262288
|
| 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. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| 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 |
|---|
| 68163-700-08 | 237 mL in 1 BOTTLE (68163-700-08) | 26 Aug, 2020 | 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:
Extra strength gas relief simethicone dimethicone dimethicone carboxymethylcellulose sodium, unspecified anhydrous citric acid glycerin microcrystalline cellulose polysorbate 60 potassium sorbate water sodium benzoate sorbitan monostearate sorbitol sucralose xanthan gum
Indications and Usage:
Uses for the relief of pressure, bloating, and fullness commonly referred to as gas
Warnings:
Warnings if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222. quick medical attention is critical even if you do not notice any sign or symptoms.
Dosage and Administration:
Directions ⪠shake well before using ⪠do not take more than 20 ml in any 24-hour period except under the advice and supervision of a physician ⪠measure only with dosing cup provided ⪠do not use dosing cup with other products ⪠ml = milliliter ⪠adults : 5 ml or 10 ml in dosing cup provided as needed after meals and at bedtime. ⪠do not exceed 4 soft gels in 24 hours unless directed by a doctor
Package Label Principal Display Panel:
Principal display panel safe and effective relief nurelief ⢠ndc# 68163-700-08 relieves gas, bloating & abdominal discomfort extra strength gas relief liquid simethicone 125mg/anti-gas fast relief relives gas, bloating & abdominal discomfort dye & sugar free tropical fruit flavor naturally flavored 48 doses dosage cup included 8 fl oz (237 ml) important: keep this carton for future reference on full labeling. distributed by lifelab health llc 5300 w hillsboro blvd, suite 202 coconut creek, fl 33073 www.nurelief.com made in usa tamper evident: do not use if carton is opened or if blister unit is torn, broken or shows any signs of tampering. nurelief gas relief liquid tropical fruit
Further Questions:
Questions or comments? call 1-866-467-2748