VIRTUSSIN DAC- codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid 
Virtus Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Virtussin DAC

Drug Facts

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.


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.

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

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

VIRTUSSIN DAC 
codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69543-253
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCARAMEL, CHERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69543-253-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/31/2019
Labeler - Virtus Pharmaceuticals (079659493)

Revised: 7/2021
Document Id: 2cfe8bec-27af-4fad-920e-d649e77a4d21
Set id: 58c3df87-86a9-4058-971f-b26e3fc0cb97
Version: 2
Effective Time: 20210713
 
Virtus Pharmaceuticals