{"active_ingredient":["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"],"active_ingredient_table":["<table width=\"100%\"><col width=\"37%\"/><col width=\"30%\"/><tbody><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 5 mL = 1 tsp)</content></content></paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>Codeine phosphate, USP 10 mg</paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Lrule Toprule Botrule \"><paragraph>Cough Suppressant</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Lrule Toprule Botrule \"><paragraph>Expectorant</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph>Pseudoephedrine HCl, USP 30 mg</paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph>Nasal Decongestant</paragraph></td></tr></tbody></table>"],"dosage_and_administration":["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."],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"44%\"/><col width=\"53%\"/><tbody><tr><td valign=\"top\" styleCode=\"Rrule Botrule Toprule \"><list listType=\"unordered\"><item><caption> </caption>Adults and children 12 years of age and over:</item></list></td><td valign=\"top\" styleCode=\"Botrule Lrule Toprule \"><list listType=\"unordered\"><item><caption> </caption>2 tsp (10 mL) every 4 hours, or as directed by a doctor.</item></list></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Botrule \"><list listType=\"unordered\"><item><caption> </caption>Children 6 to under 12 years of age:</item></list></td><td valign=\"top\" styleCode=\"Lrule Toprule Botrule \"><list listType=\"unordered\"><item><caption> </caption>1 tsp (5 mL) every 4 hours, or as directed by a doctor.</item></list></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Botrule Toprule \"><list listType=\"unordered\"><item><caption> </caption>Children under 6 years of age:</item></list></td><td valign=\"top\" styleCode=\"Botrule Lrule Toprule \"><list listType=\"unordered\"><item><caption> </caption>Consult a doctor.</item></list></td></tr></tbody></table>"],"effective_time":"20220818","id":"36f52bd0-64fc-4330-b625-6fc9bb414a15","inactive_ingredient":["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."],"indications_and_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"],"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."],"openfda":{},"package_label_principal_display_panel":["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 118 mL Bottle Label"],"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"],"purpose_table":["<table width=\"100%\"><col width=\"37%\"/><col width=\"30%\"/><tbody><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 5 mL = 1 tsp)</content></content></paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Purpose</content></content></paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>Codeine phosphate, USP 10 mg</paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Lrule Toprule Botrule \"><paragraph>Cough Suppressant</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Lrule Botrule \"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Lrule Toprule Botrule \"><paragraph>Expectorant</paragraph></td></tr><tr><td valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph>Pseudoephedrine HCl, USP 30 mg</paragraph></td><td align=\"right\" valign=\"top\" styleCode=\"Rrule Botrule Lrule Toprule \"><paragraph>Nasal Decongestant</paragraph></td></tr></tbody></table>"],"set_id":"58c3df87-86a9-4058-971f-b26e3fc0cb97","spl_product_data_elements":["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"],"spl_unclassified_section":["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.","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.","Manufactured for: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 1-888-848-3593 Rev. 11/2018 Made in USA 7269-0004"],"version":"3","warnings":["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"]}