NDC 69543-253 Virtussin Dac
Codeine Phosphate, Guaifenesin, And Pseudoephedrine Hydrochloride Liquid Oral

Product Information

What is NDC 69543-253?

The NDC code 69543-253 is assigned by the FDA to the product Virtussin Dac which is a human over the counter drug product labeled by Virtus Pharmaceuticals. The generic name of Virtussin Dac is codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 69543-253-04 118 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 Code69543-253
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.
Virtussin Dac
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.
Codeine Phosphate, Guaifenesin, And Pseudoephedrine Hydrochloride
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 FormLiquid - 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) 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.
Virtus Pharmaceuticals
Labeler Code69543
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
DEA Schedule What is the Drug Enforcement Administration (DEA) CV Schedule?
The controlled substances in the CV schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the United States. Substances in schedule CV are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes. Buprenorphine is also a CV schedule drug.
Schedule V (CV) Substances
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.
01-31-2019
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
11-30-2022
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 Virtussin Dac?


Product Characteristics

Flavor(s)CARAMEL (C73373)
CHERRY (C73375)
MENTHOL (C73403)

Product Packages

NDC Code 69543-253-04

Package Description: 118 mL in 1 BOTTLE

Product Details

What are Virtussin Dac 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.
  • CODEINE PHOSPHATE 10 mg/5mL - An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.
  • GUAIFENESIN 100 mg/5mL - An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
  • PSEUDOEPHEDRINE HYDROCHLORIDE 30 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.

Virtussin Dac Active Ingredients UNII Codes

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: 995983 - codeine phosphate 10 MG / guaiFENesin 100 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution
  • RxCUI: 995983 - codeine phosphate 2 MG/ML / guaifenesin 20 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
  • RxCUI: 995983 - codeine phosphate 10 MG / guaifenesin 100 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution

Virtussin Dac 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)

* Please review the disclaimer below.

Patient Education

Codeine

Codeine is pronounced as (koe' deen)

Why is codeine medication prescribed?
Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Combination products that contain co...
[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]
Pseudoephedrine

Pseudoephedrine is pronounced as (soo doe e fed' rin)
Why is pseudoephedrine medication prescribed?
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseud...
[Read More]

* Please review the disclaimer below.

Virtussin Dac 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



Otc - Purpose



Active ingredients
(in each 5 mL = 1 tsp)

Purpose

Codeine phosphate, USP 10 mg

Cough Suppressant

Guaifenesin, USP 100 mg

Expectorant

Pseudoephedrine HCl, USP 30 mg

Nasal Decongestant


Uses



  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪temporarily relieves nasal congestion due to the common cold
  • ▪temporarily restores freer breathing through the nose
  • ▪helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • ▪calms the cough control center and relieves coughing

Warnings



Ask your doctor before use if you have

  • ▪heart disease
  • ▪high blood pressure
  • ▪thyroid disease
  • ▪diabetes
  • ▪trouble urinating due to enlarged prostate gland
  • ▪cough that occurs with excessive phlegm (mucus)
  • ▪cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Do Not Use



  • ▪in a child under 2 years of age
  • ▪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.
  • ▪if you or your child has a chronic pulmonary disease or shortness of breath
  • ▪if your child is taking other drugs, unless directed by a doctor

When Using This Product



  • do not use more than directed
  • ▪may cause drowsiness
  • ▪constipation may occur or be aggravated

Stop Use And Ask A Doctor If



  • ▪you get nervous, dizzy, or have trouble sleeping
  • ▪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 - Keep Out Of Reach Of Children




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

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


Directions



  • ▪do not exceed 4 doses in any 24 hour period.
  • Adults and children 12 years of age and over:2 tsp (10 mL) every 4 hours, or as directed by a doctor.Children 6 to under 12 years of age:1 tsp (5 mL) every 4 hours, or as directed by a doctor.Children under 6 years of age:Consult a doctor.
     
     
     
     
     
     
    •  Attention: A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

Other Information



Each tsp (5 mL) contains 3 mg sodium.
Store at controlled room temperature 15°-30°C (59°-86°F).
You may report side effects by calling 1-888-848-3593 or FDA at 1-800-FDA-1088.


Inactive Ingredients



Alcohol, caramel flavor, cherry flavor, citric acid, FD&C red #40, glycerin, menthol flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol 70% solution.


Other



Manufactured for:
Virtus Pharmaceuticals, LLC
Langhorne, PA 19047
1-888-848-3593

Rev. 11/2018
Made in USA
7269-0004


Principal Display Panel – 118 Ml Bottle Label





NDC:
69543-253-04

Virtussin DAC

Cough Suppressant
Expectorant
Nasal Decongestant

CV

SUGAR FREE • 2.1% (v/v) ALCOHOL

Each 5 mL (1 teaspoonful) contains:

Codeine phosphate, USP 10 mg
Guaifenesin, USP 100 mg
Pseudoephedrine HCl, USP 30 mg
(WARNING: May be habit-forming)

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

4 fl. oz. (118 mL)

VIRTUS®
PHARMACEUTICALS


* Please review the disclaimer below.