NDC 0904-6759 Robafen Dm
Dextromethorphan Hbr, Guaifenesin Solution Oral

Product Information

Robafen Dm is a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Robafen Dm is dextromethorphan hbr, guaifenesin. The product's dosage form is solution and is administered via oral form.

Product Code0904-6759
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Robafen Dm
Non-Proprietary Name 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.
Dextromethorphan Hbr, Guaifenesin
Product Type 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.
Human Otc Drug
Dosage FormSolution - 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Major Pharmaceuticals
Labeler Code0904
FDA Application Number 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.
part341
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
11-29-2018
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Robafen Dm?


Product Characteristics

Flavor(s)CHERRY (C73375)

Product Packages

NDC 0904-6759-20

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

Price per Unit: $0.01577 per ML

Product Details

What are Robafen 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/10mL - 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 200 mg/10mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

NDC to RxNorm Crosswalk

What is RxNorm? 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: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution

Inactive Ingredient(s)

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.
  • ASPARTAME (UNII: Z0H242BBR1)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • WATER (UNII: 059QF0KO0R)
  • MENTHOL (UNII: L7T10EIP3A)

Pharmacologic Class(es)

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.

Robafen Dm Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each 10 Ml)



Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg


Purposes



Cough suppressant

Expectorant


Uses



  • •temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • •helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Do Not Use



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.


Ask A Doctor Before Use If You Have



  • •cough that occurs with too much phlegm (mucus)
  • •cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor If



cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • •do not take more than 6 doses in any 24-hour period
  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •mL = milliliter
  • •this adult product is not intended for use in children under 12 years of age
  • age

    dose

    adults and children

    12 years and over

    10 mL

    every 4 hours

    children under 12 years

    do not use


Other Information



  • Phenylketonurics:Contains Phenylalanine 30 mg per 10 mL
  • •store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients



aspartame, benzoic acid, flavor, glycerin, hydroxyethyl cellulose, menthol, polyethylene glycol, purified water


Questions Or Comments?



1-800-616-2471


Principal Display Panel



ROBAFEN® DM COUGH

SUGAR-FREE

CLEAR

COUGH SUPPRESSANT (Dextromethorphan HBr)

EXPECTORANT (Guaifenesin)

Relieves:

Cough

Chest Congestion

Non-Drowsy

Specially Formulated For DIABETICS

COMPARE TO the active ingredients of ROBITUSSIN® SUGAR-FREE COUGH + CONGESTION DM

FOR ADULTS

Ages 12 and Over

4 FL. OZ. (118 mL)


* Please review the disclaimer below.