Virtussin DAC Codeine phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride Codeine phosphate Codeine Anhydrous Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine Alcohol citric acid monohydrate FD&C red no. 40 glycerin potassium citrate propylene glycol water sodium benzoate saccharin sodium sorbitol
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label VIRTUS PHARMACEUTICALS NDC: 69543 -253- 16 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. 16 fl. oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label VIRTUS PHARMACEUTICALS NDC: 69543 -253- 16 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. 16 fl. oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Overview
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
Indications & Usage
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 & Administration
Directions • do not exceed 4 doses in any 24 hour period. 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. 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.
Warnings & Precautions
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.
Purpose
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
Do Not Use
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
When using this product • do not use more than directed • may cause drowsiness • constipation may occur or be aggravated
Stop Use & Ask a Doctor
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
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
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.
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