NDC | 69543-253-04 |
Set ID | 58c3df87-86a9-4058-971f-b26e3fc0cb97 |
Category | HUMAN OTC DRUG LABEL |
Packager | Virtus Pharmaceuticals |
Generic Name | |
Product Class | alpha-Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
-
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
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
-
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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
-
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 liquidProduct 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)