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.
What are the uses for Virtussin Dac?
This product is used as Active ingredients(in each 5 mL = 1 tsp)PurposeCodeine phosphate, USP 10 mgCough SuppressantGuaifenesin, USP 100 mgExpectorantPseudoephedrine HCl, USP 30 mgNasal Decongestant. ▪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
Product Characteristics
Flavor(s) | CARAMEL (C73373) CHERRY (C73375) MENTHOL (C73403) |
Product Details
What are Virtussin Dac Active Ingredients?
- 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
- CODEINE PHOSPHATE (UNII: GSL05Y1MN6)
- CODEINE ANHYDROUS (UNII: UX6OWY2V7J) (Active Moiety)
- GUAIFENESIN (UNII: 495W7451VQ)
- GUAIFENESIN (UNII: 495W7451VQ) (Active Moiety)
- PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N)
- PSEUDOEPHEDRINE (UNII: 7CUC9DDI9F) (Active Moiety)
NDC to RxNorm Crosswalk
- 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
- ALCOHOL (UNII: 3K9958V90M)
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GLYCERIN (UNII: PDC6A3C0OX)
- POTASSIUM CITRATE (UNII: EE90ONI6FF)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- SORBITOL (UNII: 506T60A25R)
Pharmacologic Class(es)
- Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Full Opioid Agonists - [MoA] (Mechanism of Action)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Opioid Agonist - [EPC] (Established Pharmacologic Class)
- alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
* Please review the disclaimer below.
Patient Education
Codeine
Codeine is pronounced as (koe' deen)
Why is codeine medication prescribed?Guaifenesin
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 is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?Pseudoephedrine
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 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 | 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.
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.