Rynex Pse
Brompheniramine Maleate And Pseudoephedrine Hydrochloride
Edwards Pharmaceuticals, Inc.
Human Otc Drug
NDC 0485-0206Rynex Pse also known as Brompheniramine Maleate And Pseudoephedrine Hydrochloride is a human otc drug labeled by 'Edwards Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Rynex Pse is 0485-0206. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Rynex Pse drug includes Brompheniramine Maleate - 1 mg/5mL Pseudoephedrine Hydrochloride - 15 mg/5mL . The currest status of Rynex Pse drug is Active.
Drug Information:
| Drug NDC: | 0485-0206 |
| 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: | Rynex Pse |
| 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: | Brompheniramine Maleate And Pseudoephedrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Edwards 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: | BROMPHENIRAMINE MALEATE - 1 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE - 15 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: | 07 Mar, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | 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: | EDWARDS PHARMACEUTICALS, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1098498
|
| 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. |
| UPC: | 0304850206163
|
| UPC stands for Universal Product Code. |
| UNII: | IXA7C9ZN03
6V9V2RYJ8N
|
| 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 alpha-Agonists [MoA]
alpha-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 |
|---|
| 0485-0206-16 | 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) | 07 Mar, 2011 | 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:
Active ingredients (in each 5 ml teaspoonful) purpose brompheniramine maleate 1 mg antihistamine pseudoephedrine hci 15 mg decongestant
Product Elements:
Rynex pse brompheniramine maleate and pseudoephedrine hydrochloride citric acid monohydrate fd&c red no. 40 fd&c yellow no. 6 methylparaben propylparaben propylene glycol water sodium citrate sucralose brompheniramine maleate brompheniramine pseudoephedrine hydrochloride pseudoephedrine
Indications and Usage:
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion 'reduces swelling of nasal passages
Warnings:
Warnings do not exceed recommended dosage. do not use this product if you are now taking a prescription monoamine oxidase inhibitor (ma0i) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the ma0i drug. if you do not know if your prescription drug contains an ma0i, ask a doctor or pharmacist before taking this product do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor. when using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machiner
Read more...y stop use and ask doctor if nervousness, dizziness, or sleeplessness occur if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor new symptoms occur keep out of reach of children. in case of accidental overdose, seek professional help or contact a poison control center immediately.
Do Not Use:
Warnings do not exceed recommended dosage. do not use this product if you are now taking a prescription monoamine oxidase inhibitor (ma0i) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the ma0i drug. if you do not know if your prescription drug contains an ma0i, ask a doctor or pharmacist before taking this product do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor. when using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask doctor if nervousness, dizziness, or sleeplessness occur if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor new symptoms occur keep out of reach of children. in case of accidental overdose, seek professional help or contact a poison control center immediately.
When Using:
When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not exceed recommended dosage adults and children 12 years of age and over: 4 teaspoonfuls (20 ml) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours children 6 to under 12 years of age: 2 teaspoonfuls (10 ml) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours children under 6 years of age consult a doctor
Stop Use:
Stop use and ask doctor if nervousness, dizziness, or sleeplessness occur if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor new symptoms occur
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc 00485-0206-16 rynex pse antihistamine ⢠decongestant sugar free ⢠alcohol free ⢠gluten free each teaspoonful (5 ml) for oral administration contains: brompheniramine maleate 1 mg pseudoephedrine hci 15 mg orange flavor for professional use only this bottle is not to be dispensed to consumer. tamper evident by foil seal under cap. do not used foil seal is broken or missing. dispense in a tight container with a child- resistant cap. manufactured for: edwards pharmaceuticals, inc. ripley, ms 38663 16oz. (473 ml) label
Further Questions:
Question? comments? call 1-800-543-9560