NDC 58809-850 Vanacof Dmx

Dextromethorphan Hydrobromide Liquid Oral

NDC Product Information

Vanacof Dmx with NDC 58809-850 is a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Vanacof Dmx is dextromethorphan hydrobromide. The product's dosage form is liquid and is administered via oral form.

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.

Product Type: Human Otc Drug 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.

Vanacof Dmx Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

Inactive Ingredient(s)

About the 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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Product Labeler Information

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

Labeler Name: Gm Pharmaceuticals, Inc
Labeler Code: 58809
FDA Application Number: part341 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 12-12-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Vanacof Dmx Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

(in each 15 mL)Dextromethorphan HBr 18 mg.........Cough SuppressantGuaifenesin 396 mg......................................ExpectorantPhenylephrine HCl 10 mg................Nasal Decongestant


Cough SuppressantExpectorantNasal Decongestant


■ temporarily relieves:■ cough due to minor throat and bronchial irritation asmay occur with the common cold or inhaled irritants■ the intensity of coughing■ nasal congestion due to a cold■ the impulse to cough to help you get to sleep■ helps loosen phlegm (mucus) and thin bronchialsecretions to rid the bronchial passageways of bothersome mucus and make coughs more productive


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 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

■ heart disease
■ high blood pressure ■ thyroid disease
■ diabetes■ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema■ a cough that occurs with too much phlegm (mucus)■ difficulty in urination due to enlargement of the prostate gland

Stop Use And Ask A Doctor If

■ symptoms do not improve within 7 days or are accompanied by afever, rash or persistent headache. A persistent cough may be a sign of a serious condition.■ nervousness, dizziness, or sleeplessness occurs■ new symptoms occur

Keep Out Of Reach Of Children.

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


■ do not take more than 6 doses in any 24-hour period■ use enclosed dosage cup or tablespoon (TBSP)■ dose as follows or as directed by a doctoradults and children 12 years of age and over:15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period.children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.children under 6 years of age:Consult a doctor.

Other Information

■ each 15 mL contains: Sodium 6 mg■ this packaging is child-resistant.■ read all product information before using■ store at 20° to 30°C (68° to 86°F)

Inactive Ingredients

Citric acid, flavors, glycerin, L-menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

* Please review the disclaimer below.