{"active_ingredient":["Active ingredients (in each 5 mL = 1 tsp) Purpose Codeine phosphate, USP 10 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant"],"active_ingredient_table":["<table width=\"73.5%\"><col width=\"51%\"/><col width=\"23%\"/><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=\"right\" 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 align=\"right\" styleCode=\"Toprule \" valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td align=\"right\" styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"ask_doctor":["Ask your doctor before use if ▪ you have a persistent cough, this may be a sign of a serious condition ▪ you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ you have a cough that is accompanied by excessive phlegm (mucus) ▪ you have chronic pulmonary disease or shortness of breath ▪ giving to a child who is taking other drugs"],"dosage_and_administration":["Directions ▪ do not exceed 6 doses in 24 hours. 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=\"65%\"><col width=\"33%\"/><col width=\"32%\"/><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 Toprule Botrule \" valign=\"top\"><paragraph>Children 6 to under 12 years  of age:</paragraph></td><td styleCode=\"Toprule 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":"20230303","how_supplied":["HOW SUPPLIED NDC: 63629-2487-1: 118 mL Oral Solution 10-100 mg/5 mL in a BOTTLE"],"id":"b87590f2-ae9d-4fb9-843a-e2043edcb4f6","inactive_ingredient":["Inactive ingredients Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose. Manufactured for: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 1-888-848-3593 Made in USA Rev. 07/2019 7270-0016"],"indications_and_usage":["Uses ▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants ▪ your cough to help you sleep ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."],"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":["Guaifenesin-Codeine Solution 100-10mg/5ml 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"],"purpose_table":["<table width=\"73.5%\"><col width=\"51%\"/><col width=\"23%\"/><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=\"right\" 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 align=\"right\" styleCode=\"Toprule \" valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td align=\"right\" styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"set_id":"db8bff74-545a-42c6-816c-5327ba9c634c","spl_product_data_elements":["Virtussin AC Codeine phosphate and Guaifenesin CODEINE PHOSPHATE CODEINE ANHYDROUS GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE METHYLPARABEN POTASSIUM CITRATE POTASSIUM SORBATE PROPYLPARABEN PROPYLENE GLYCOL WATER SORBITOL SUCRALOSE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if ▪ symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition."],"storage_and_handling":["Other information 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":"103","warnings":["Warnings Ask your doctor before use if ▪ you have a persistent cough, this may be a sign of a serious condition ▪ you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ▪ you have a cough that is accompanied by excessive phlegm (mucus) ▪ you have chronic pulmonary disease or shortness of breath ▪ giving to a child who is taking other drugs When using this product ▪ giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. ▪ may cause or aggravate constipation Stop use and ask a doctor if ▪ symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms 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 ▪ giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. ▪ may cause or aggravate constipation"]}