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NDC 12830-816 M-end Dmx

Dexbrompheniramine Maleate,Dextromethorphan Hydrobromide,Pseudoephedrine Hydrochloride - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 12830-816?
  5. M-end Dmx Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
12830-816
Proprietary Name:
M-end Dmx
Non-Proprietary Name: [1]
Dexbrompheniramine Maleate, Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride
Substance Name: [2]
Dexbrompheniramine Maleate; Dextromethorphan Hydrobromide; 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]
    R. A. Mcneil Company
    Labeler Code:
    12830
    Product Label ID:
    ee1fae2e-3a21-4487-9989-c7620a4a7056
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    10-13-2011
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Flavor(s):
    TUTTI FRUTTI (C73420)

    Code Structure Chart

    Product Details

    What is NDC 12830-816?

    The NDC code 12830-816 is assigned by the FDA to the product M-end Dmx which is a human over the counter drug product labeled by R. A. Mcneil Company. The generic name of M-end Dmx is dexbrompheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride. The product's dosage form is liquid and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 12830-816-16 473 ml in 1 bottle , 12830-816-30 30 ml in 1 bottle . 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 M-end Dmx?

    Do not exceed 4 doses in a 24 hour period.Adults and children 12 years of age and over: 3 teaspoonfuls (15 mL) every 6 hours, not to exceed 12 teaspoonfuls in 24 hours Children 6 to under 12 years of age: 1 1/2 teaspoonfuls (7.5 mL) every 6 hours, not to exceed 6 teaspoonfuls in 24 hours Children under 6 years of age: Consult a Physician.

    What are M-end Dmx 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.
    • DEXBROMPHENIRAMINE MALEATE .667 mg/5mL
    • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    • PSEUDOEPHEDRINE HYDROCHLORIDE 20 mg/5mL - A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

    Which are M-end Dmx UNII Codes?

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

    • DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS)
    • DEXBROMPHENIRAMINE (UNII: 75T64B71RP) (Active Moiety)
    • DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
    • DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
    • PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N)
    • PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (Active Moiety)

    Which are M-end Dmx 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:

    Which are the Pharmacologic Classes for M-end Dmx?

    * 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]


    * 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.

    [6] What is the FDA Application Number? - 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.

    [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".