Country: United States
Language: English
Source: NLM (National Library of Medicine)
Codeine phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J), Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F)
Virtus Pharmaceuticals
ORAL
OTC DRUG
OTC monograph final
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._ ---------- 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 US ES • • • • • WARNINGS ASK YOUR DOCTOR BEFORE USE IF YOU HAVE • • • • • • • DO NOT USE • • • • WHEN USING THIS PRODUCT 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 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 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 • • • STOP USE AND ASK A DOCTOR IF • • 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 Read the complete document