{"active_ingredient":["Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant"],"active_ingredient_table":["<table width=\"60%\"><col width=\"37%\"/><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 (teaspoonful)</content></content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</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 styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if you have • a cough with too much phlegm (mucus) • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone."],"do_not_use":["Do not use • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor."],"dosage_and_administration":["Directions • take every 4 hours • do not exceed 6 doses in 24 hours • 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 can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Consult a doctor"],"dosage_and_administration_table":["<table width=\"60%\"><col width=\"33%\"/><col width=\"27%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Botrule Toprule \" valign=\"top\"><paragraph>10 mL (2 teaspoonfuls)</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>5 mL (1 teaspoonful)</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":"20210526","id":"d72bd868-e09d-429c-83c0-89db6db95e88","inactive_ingredient":["Inactive ingredients Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol."],"indications_and_usage":["Uses • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparation is not recommended for children under 2 years of age."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 68788-7608-1 Guaifenesin and Codeine Phosphate Oral Solution USP CV 100 mg/10 mg per 5 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Each teaspoonful (5 mL) contains: Guaifenesin, USP 100 mg Codeine Phosphate, USP 10 mg Dispense in a tight, light-resistant container with a child-resistant closure. DO NOT ACCEPT IF SEAL AROUND CAP IS BROKEN OR MISSING 16 fl oz (473 mL) pai Pharmaceutical Associates, Inc. Greenville, SC 29605 Relabeled By: Preferred Pharmaceuticals Inc. Guaifenesin and Codiene Oral Solution 10-100mg5mL (CIV)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant"],"purpose_table":["<table width=\"60%\"><col width=\"37%\"/><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 (teaspoonful)</content></content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</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 styleCode=\"Botrule \" valign=\"top\"><paragraph>Guaifenesin, USP 100 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Expectorant</paragraph></td></tr></tbody></table>"],"questions":["Questions or comments? Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number."],"set_id":"7ebbdd26-0856-4ac3-8b2f-0464dd25f7be","spl_product_data_elements":["Guaifenesin and Codeine Phosphate Guaifenesin and Codeine Phosphate CITRIC ACID MONOHYDRATE EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN MENTHOL, UNSPECIFIED FORM PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL GUAIFENESIN GUAIFENESIN CODEINE PHOSPHATE CODEINE ANHYDROUS"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. • may cause or aggravate constipation"],"storage_and_handling":["Other information • Sodium Content: 5 mg/5 mL • Tamper evident: Do not use if seal under cap is broken or missing • Keep container closed and store away from heat • Store at 20°- 25°C (68°-77°F)"],"version":"2","warnings":["Warnings Do not use • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. Ask a doctor before use if you have • a cough with too much phlegm (mucus) • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone. Stop use and ask a doctor if • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. • may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. • Use of codeine-containing preparation is not recommended for children under 2 years of age."]}