NDC 0485-0206 Rynex Pse

Brompheniramine Maleate And Pseudoephedrine Hydrochloride Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0485-0206
Proprietary Name:
Rynex Pse
Non-Proprietary Name: [1]
Brompheniramine Maleate And Pseudoephedrine Hydrochloride
Substance Name: [2]
Brompheniramine Maleate; Pseudoephedrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Edwards Pharmaceuticals, Inc.
    Labeler Code:
    0485
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    03-07-2011
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331)
    Flavor(s):
    ORANGE (C73406)

    Product Packages

    NDC Code 0485-0206-16

    Package Description: 473 mL in 1 BOTTLE, PLASTIC

    Price per Unit: $0.03644 per ML

    Product Details

    What is NDC 0485-0206?

    The NDC code 0485-0206 is assigned by the FDA to the product Rynex Pse which is a human over the counter drug product labeled by Edwards Pharmaceuticals, Inc.. The generic name of Rynex Pse is brompheniramine maleate and pseudoephedrine hydrochloride. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 0485-0206-16 473 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Rynex Pse?

    Do not exceed recommended dosageAdults and children 12 years of age and over:4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hoursChildren 6 to under 12 years of age:2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hoursChildren 2 to under 6 years of age1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hoursChildren under 2 years of ageConsult a doctor

    What are Rynex Pse Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Rynex Pse UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Rynex Pse Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Rynex Pse?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1098498 - brompheniramine maleate 1 MG / pseudoephedrine HCl 15 MG in 5 mL Oral Solution
    • RxCUI: 1098498 - brompheniramine maleate 0.2 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution
    • RxCUI: 1098498 - brompheniramine maleate 1 MG / pseudoephedrine hydrochloride 15 MG per 5 ML Oral Solution

    Which are the Pharmacologic Classes for Rynex Pse?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Brompheniramine


    Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    Pseudoephedrine


    Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".