NDC 0031-8759 Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm
Dextromethorphan Hydrobromide, Guaifenesin Solution Oral

Product Information

What is NDC 0031-8759?

The NDC code 0031-8759 is assigned by the FDA to the product Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Robitussin Sugar-free Dye-free 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 a single package with assigned NDC code 0031-8759-12 1 bottle in 1 carton / 118 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, RxNorm crosswalk and the complete product label.

NDC Product Code0031-8759
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.		Robitussin Sugar-free Dye-free Cough Plus Chest Congestion 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 Hydrobromide, 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.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0031
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.		02-16-2018
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.		12-31-2024
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 Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm?


Product Characteristics

Flavor(s)MENTHOL (C73403)

Product Packages

NDC Code 0031-8759-12

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

Product Details

What are Robitussin Sugar-free Dye-free 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 200 mg/20mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.

Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm Active Ingredients UNII Codes

Robitussin Sugar-free Dye-free 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.

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.

Patient Education

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
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 th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
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 cla...
[Read More]

* Please review the disclaimer below.

Robitussin Sugar-free Dye-free Cough Plus Chest Congestion Dm Product Label

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.

Product Label Table of Contents



Other



Drug Facts

Distributed by:
Pfizer, Madison, NJ 07940 USA


Otc - Purpose



Active ingredients (in each 20 ml)Purposes

Dextromethorphan HBr, USP 20 mg

Cough suppressant

Guaifenesin, USP 200 mg

Expectorant


Indications & Usage



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

Warnings



Warnings


Otc - Do Not Use



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

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & Administration



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
    • agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children under 12 years

    do not use


Storage And Handling



Other information

  • •each 20 ml contains: sodium 20 mg
  • •store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredient



Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, glycerin, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, triacetin, xanthan gum


Otc - Questions



Questions or comments?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675


Principal Display Panel - 118 Ml Bottle Label



ADULT

Robitussin®

SUGAR-FREE
DYE-FREE

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

Non-Drowsy

4 FL OZ (118 ml)

Principal Display Panel - 118 ml Bottle Label - robitussin 01

Principal Display Panel - 118 ml Bottle Label - robitussin 01


Principal Display Panel - 118 Ml Bottle Carton



ADULT

See
New
Dosing

Robitussin®

SUGAR-FREE
DYE-FREE

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

* Please review the disclaimer below.