NDC 0031-8739 Robitussin Maximum Strength Cough Plus Chest Congestion Dm

Dextromethorphan Hydrobromide,Guaifenesin Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0031-8739
Proprietary Name:
Robitussin Maximum Strength Cough Plus Chest Congestion Dm
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, Guaifenesin
Substance Name: [2]
Dextromethorphan Hydrobromide; Guaifenesin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Haleon Us Holdings Llc
    Labeler Code:
    0031
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    06-01-2016
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)

    Product Packages

    NDC Code 0031-8739-12

    Package Description: 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE

    NDC Code 0031-8739-18

    Package Description: 1 BOTTLE in 1 CARTON / 237 mL in 1 BOTTLE

    NDC Code 0031-8739-42

    Package Description: 1 BOTTLE in 1 CARTON / 355 mL in 1 BOTTLE

    Product Details

    What is NDC 0031-8739?

    The NDC code 0031-8739 is assigned by the FDA to the product Robitussin Maximum Strength Cough Plus Chest Congestion Dm which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Robitussin Maximum Strength Cough Plus Chest Congestion Dm is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is solution and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0031-8739-12 1 bottle in 1 carton / 118 ml in 1 bottle, 0031-8739-18 1 bottle in 1 carton / 237 ml in 1 bottle, 0031-8739-42 1 bottle in 1 carton / 355 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 Robitussin Maximum Strength Cough Plus Chest Congestion Dm?

    Do not take more than 6 doses in any 24-hour periodmeasure only with dosing cup providedkeep dosing cup with productml = milliliterthis adult product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over20 ml every 4 hourschildren under 12 yearsdo not use

    What are Robitussin Maximum Strength Cough Plus Chest Congestion Dm 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.
    • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL - 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.
    • GUAIFENESIN 400 mg/20mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

    Which are Robitussin Maximum Strength Cough Plus Chest Congestion Dm UNII Codes?

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

    Which are Robitussin Maximum Strength Cough Plus Chest Congestion Dm 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 Robitussin Maximum Strength Cough Plus Chest Congestion Dm?

    * Please review the disclaimer below.

    Patient Education

    Dextromethorphan


    Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
    [Learn More]


    Guaifenesin


    Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
    [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".