Rynex Dm
Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Edwards Pharmaceuticals, Inc
Human Otc Drug
NDC 0485-0204Rynex Dm also known as Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride is a human otc drug labeled by 'Edwards Pharmaceuticals, Inc'. National Drug Code (NDC) number for Rynex Dm is 0485-0204. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Rynex Dm drug includes Brompheniramine Maleate - 1 mg/5mL Dextromethorphan Hydrobromide - 5 mg/5mL Phenylephrine Hydrochloride - 2.5 mg/5mL . The currest status of Rynex Dm drug is Active.
Drug Information:
| Drug NDC: | 0485-0204 |
| 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 Dm |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Rynex |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | DM |
| 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: | Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine 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
DEXTROMETHORPHAN HYDROBROMIDE - 5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 2.5 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: | 14 Mar, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | 1090463
|
| 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: | IXA7C9ZN03
9D2RTI9KYH
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]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [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 |
|---|
| 0485-0204-04 | 118 mL in 1 BOTTLE, PLASTIC (0485-0204-04) | 14 Mar, 2011 | N/A | No |
| 0485-0204-16 | 473 mL in 1 BOTTLE (0485-0204-16) | 14 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:
Purpose antihistamine antitussive nasal decongestant
Product Elements:
Rynex dm brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride citric acid monohydrate glycerin propylene glycol water methylparaben propylparaben brompheniramine maleate brompheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine
Indications and Usage:
Uses temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation 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 (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. do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlarged prostate gland do not take 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 marked drowsiness sedatives, and tranquilizers may increase the drowsiness effect avoid alcoho
Read more...lic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. these could be signs of a serious condition new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of the reach of children. in case of 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 (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. do not use this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis glaucoma a persistent or chronic cough that occurs with too much phlegm heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlarged prostate gland do not take 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 marked drowsiness sedatives, and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. these could be signs of a serious condition new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of the reach of children. in case of 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 marked drowsiness sedatives, and tranquilizers may increase the 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 older: 4 teaspoonfuls (20 ml) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor children 6 to under 12 years of age: 2 teaspoonfuls (10 ml) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours, or as directed by a doctor. children under 6 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. these could be signs of a serious condition new symptoms occur
Package Label Principal Display Panel:
Product packaging the packaging below represents the labeling currently used: principal display panel and side panel for 473 ml label: ndc 00485-0204-16 rynex dm liquid antihistamine â antitussive nasal decongestant each 5 ml (one teaspoonful) for oral administration contains: brompheniramine maleate, usp..................1 mg dextromethorphan hbr, usp.......................5 mg phenylephrine hcl, usp...........................2.5 mg alcohol free â dye free gluten free â sugar free ______________________________________________ for professional use only tutti-frutti flavor manufactured for: edwards pharmaceuticals, inc. ripley, ms 38663 16 fl oz (473 ml) tamper evident by foil seal under cap. do not use if foil seal is broken or missing. dispense in a tight, light-resistant container with a child-resistant cap. this bottle is not to be dispensed to the consumer. the labeling for this product includes professional labeling which is not intended for use by the general public. manufactured for: edwards pharmaceuticals, inc., ripley, ms 38663 label back
Further Questions:
Questions? comments? call 1-800-543-9560