Nasal Decongestant
Phenylephrine Hcl
Spirit Pharmaceuticals Llc
Human Otc Drug
NDC 68210-4109Nasal Decongestant also known as Phenylephrine Hcl is a human otc drug labeled by 'Spirit Pharmaceuticals Llc'. National Drug Code (NDC) number for Nasal Decongestant is 68210-4109. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Nasal Decongestant drug includes Phenylephrine Hydrochloride - 10 mg/1 . The currest status of Nasal Decongestant drug is Active.
Drug Information:
| Drug NDC: | 68210-4109 |
| 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: | Nasal Decongestant |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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: | Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Spirit Pharmaceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | PHENYLEPHRINE HYDROCHLORIDE - 10 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: | 11 Sep, 2020 |
| 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: | part341 |
| 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: | Spirit Pharmaceuticals LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1049182
|
| 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. |
| UNII: | 04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 68210-4109-2 | 225 TABLET in 1 BOTTLE (68210-4109-2) | 11 Sep, 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 nasal decongestant
Product Elements:
Nasal decongestant phenylephrine hcl carnauba wax silicon dioxide croscarmellose sodium d&c yellow no. 10 aluminum lake anhydrous dibasic calcium phosphate fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 hypromellose, unspecified lactose, unspecified form magnesium stearate microcrystalline cellulose polyethylene glycol 400 sodium starch glycolate type a corn starch, corn stearic acid talc titanium dioxide phenylephrine hydrochloride phenylephrine tablet 272;s08;t234
Indications and Usage:
Uses ? temporarily relieves sinus congestion and pressure ? temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Warnings:
Warnings do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product.
When Using:
When using this product do not exceed recommended dose
Dosage and Administration:
Directions adults and children 12 years and over ? take 1 tablet every 4 hours ? do not take more than 6 tablets in 24 hours children under 12 years ask a doctor
Stop Use:
Stop use and ask a doctor if ? nervousness, dizziness, or sleeplessness occur ? symptoms do not improve within 7 days or occur with a fever 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. (1-800-222-1222)
Package Label Principal Display Panel:
Principal display panel compare to active ingredient in sudafed® pe congestion® maximum strength nasal decongestant · phenylephrine hcl 10 mg - nasal decongestant this product is not manufactured or distributed by mcneil consumer healthcare, owner of the registered trademark sudafed pe® congestion image description
Further Questions:
Questions or comments? 1-888-333-9792