{"active_ingredient":["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=\"70%\"> <col width=\"36%\"/> <col width=\"34%\"/> <thead> <tr> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Active ingredients (in each 5 mL = 1 tsp)</content> </content> </th> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Purpose</content> </content> </th> </tr> </thead> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Codeine phosphate, USP 10 mg</paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Cough Suppressant</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Guaifenesin, USP 100 mg</paragraph> </td> <td valign=\"top\"> <paragraph>Expectorant</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Pseudoephedrine HCl, USP 30 mg</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Nasal Decongestant</paragraph> </td> </tr> </tbody> </table>"],"ask_doctor":["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":["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"],"dosage_and_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."],"dosage_and_administration_table":["<table width=\"75%\"> <col width=\"38%\"/> <col width=\"38%\"/> <tfoot> <tr> <td align=\"left\" colspan=\"2\" styleCode=\"Botrule\" valign=\"top\"> <content styleCode=\"bold\">Attention:</content> 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.</td> </tr> </tfoot> <tbody> <tr> <td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"> <paragraph>Adults and children 12 years of age and over:</paragraph> </td> <td styleCode=\"Botrule Toprule \" valign=\"top\"> <paragraph>2 tsp (10 mL) every 4 hours, or as directed by a doctor.</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>Children 6 to under 12 years of age:</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>1 tsp (5 mL) every 4 hours, or as directed by a doctor.</paragraph> </td> </tr> <tr> <td styleCode=\"Rrule Botrule \" valign=\"top\"> <paragraph>Children under 6 years of age:</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Consult a doctor.</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20190308","id":"e5cd4f21-bc9d-44cd-a327-80af53df7800","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":["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 - 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"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"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=\"70%\"> <col width=\"36%\"/> <col width=\"34%\"/> <thead> <tr> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Active ingredients (in each 5 mL = 1 tsp)</content> </content> </th> <th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"> <content styleCode=\"bold\"> <content styleCode=\"italics\">Purpose</content> </content> </th> </tr> </thead> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Codeine phosphate, USP 10 mg</paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Cough Suppressant</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>Guaifenesin, USP 100 mg</paragraph> </td> <td valign=\"top\"> <paragraph>Expectorant</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Pseudoephedrine HCl, USP 30 mg</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>Nasal Decongestant</paragraph> </td> </tr> </tbody> </table>"],"set_id":"1e770927-84c6-4d43-aac8-a64e7c9201ac","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":["Drug Facts"],"stop_use":["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."],"storage_and_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."],"version":"2","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 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."],"when_using":["When using this product • do not use more than directed • may cause drowsiness • constipation may occur or be aggravated"]}