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

VIRTUSSIN DAC by

Drug Labeling and Warnings

VIRTUSSIN DAC by is a Otc medication manufactured, distributed, or labeled by Virtus Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

VIRTUSSIN DAC 
codeine phosphate, guaifenesin, and pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69543-253
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	CARAMEL, CHERRY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69543-253-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/31/2019

Labeler - Virtus Pharmaceuticals (079659493)