VIRTUSSIN DAC

Manufacturer
Virtus Pharmaceuticals
Effective date
2022-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:53:16

Label at a glance#

ProductVIRTUSSIN DAC
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure12 sections

Indications and 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

Dosage and administration

▪ 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...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • 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 SECTION


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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 mL Bottle Label118 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-253-04ML - Milliliter69543-25348525fd2-8a99-43f8-95e6-f54bff75837912019-02-13
69543-253-16ML - Milliliter69543-253b03fba34-2e05-41b2-b65c-81dc3d9a051312015-10-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69543-25369543-253-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
36f52bd0-64fc-4330-b625-6fc9bb414a1558c3df87-86a9-4058-971f-b26e3fc0cb972022-08-18WarningsExact identifier
spl id: 36f52bd0-64fc-4330-b625-6fc9bb414a15
spl set id: 58c3df87-86a9-4058-971f-b26e3fc0cb97

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.