{"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"],"active_ingredient_table":["<table width=\"100%\"><col width=\"32%\"/><col width=\"26%\"/><tbody><tr styleCode=\"First Toprule\"><td styleCode=\"Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients  (in each 5 mL = 1 tsp) </content></content></paragraph></td><td align=\"left\" styleCode=\"Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\"> Purpose</content></content></paragraph></td></tr><tr><td valign=\"top\"><paragraph>Codeine phosphate, USP 10 mg</paragraph></td><td align=\"left\" valign=\"top\"><paragraph> Cough suppressant</paragraph></td></tr><tr styleCode=\"Botrule Last\"><td styleCode=\"Botrule\" valign=\"top\"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td align=\"left\" 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=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph>Adults and children 12 years of age and over:</paragraph></td><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph>2 tsp (10 mL) every 4 hours,  or as directed by a doctor. </paragraph></td></tr><tr><td styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>Children 6 to under 12 years of age:</paragraph></td><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph>1 tsp (5 mL) every 4 hours,</paragraph><paragraph>or as directed by a doctor.</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph>Children under 6 years of age:</paragraph></td><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph>Consult a doctor.</paragraph></td></tr></tbody></table>"],"effective_time":"20230216","id":"f4d5137d-b898-9bee-e053-2a95a90a5f5a","inactive_ingredient":["Inactive ingredients Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol."],"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":["PRINCIPAL DISPLAY PANEL pdp"],"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=\"100%\"><col width=\"32%\"/><col width=\"26%\"/><tbody><tr styleCode=\"First Toprule\"><td styleCode=\"Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients  (in each 5 mL = 1 tsp) </content></content></paragraph></td><td align=\"left\" styleCode=\"Toprule\" valign=\"top\"><paragraph><content styleCode=\"bold\"><content styleCode=\"italics\"> Purpose</content></content></paragraph></td></tr><tr><td valign=\"top\"><paragraph>Codeine phosphate, USP 10 mg</paragraph></td><td align=\"left\" valign=\"top\"><paragraph> Cough suppressant</paragraph></td></tr><tr styleCode=\"Botrule Last\"><td styleCode=\"Botrule\" valign=\"top\"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\"><paragraph> Expectorant</paragraph></td></tr></tbody></table>"],"set_id":"f4d616c9-9c2c-7fa7-e053-2a95a90ac5d5","spl_product_data_elements":["GUAIFENESIN and CODEINE PHOSPHATE GUAIFENESIN and CODEINE PHOSPHATE ANHYDROUS CITRIC ACID GLYCERIN WATER SODIUM BENZOATE SACCHARIN SODIUM SORBITOL GUAIFENESIN GUAIFENESIN CODEINE PHOSPHATE CODEINE ANHYDROUS"],"spl_unclassified_section":["Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 MADE IN USA"],"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 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 1-888-344-9603 or FDA at 1-800-FDA-1088."],"version":"1","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"],"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"]}