{"active_ingredient":["Active ingredient (in each 5 mL = 1 teaspoonful) Sennosides 8.8 mg"],"ask_doctor":["Ask a doctor before use if you have stomach pain, nausea or vomiting notice a change in bowel habits that last over two weeks are pregnant or breast feeding"],"do_not_use":["Do not use laxative products for longer than one week unless directed by a doctor."],"dosage_and_administration":["Directions Shake well before using. Do not exceed maximum dose. Take at bedtime or as directed by a doctor. AGE USUAL DOSE MAXIMUM DOSAGE Adults and children 12 years and older 2-3 teaspoons (10 to 15 mL) once a day 3 teaspoons (15 mL) twice a day 6 to 12 years 1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day 1 1/2 teaspoons (7.5 mL) twice a day 2 to 6 years 1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day 3/4 teaspoon (3.75 mL) once a day under 2 years of age Consult a doctor"],"dosage_and_administration_table":["<table width=\"80%\"><col width=\"20%\" align=\"left\" valign=\"middle\"/><col width=\"35%\" align=\"left\" valign=\"middle\"/><col width=\"45%\" align=\"left\" valign=\"middle\"/><thead><tr><th styleCode=\"Lrule Rrule\">AGE</th><th styleCode=\"Rrule\">USUAL DOSE</th><th styleCode=\"Rrule\">MAXIMUM DOSAGE</th></tr></thead><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">Adults and children 12 years and older</td><td styleCode=\"Rrule\">2-3 teaspoons (10 to 15 mL) once a day</td><td styleCode=\"Rrule\">3 teaspoons (15 mL) twice a day</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">6 to 12 years</td><td styleCode=\"Rrule\">1 to 1 1/2 teaspoons (5 to 7.5 mL) once a day</td><td styleCode=\"Rrule\">1 1/2 teaspoons (7.5 mL) twice a day</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">2 to 6 years</td><td styleCode=\"Rrule\">1/2 to 3/4 teaspoons (2.5 to 3.75 mL) once a day</td><td styleCode=\"Rrule\">3/4 teaspoon (3.75 mL) once a day</td></tr><tr><td styleCode=\"Lrule Rrule\">under 2 years of age</td><td colspan=\"2\" align=\"center\" styleCode=\"Rrule\">Consult a doctor</td></tr></tbody></table>"],"effective_time":"20240530","how_supplied":["How Supplied A chocolate flavored syrup supplied in the following oral dosage cup: NDC 39328-120-05: NDC 39328-120-50: 5 mL unit dose cup Case contains 50 unit dose cups of 5 mL NDC 39328-220-15: NDC 39328-220-50: 15 mL unit dose cup Case contains 50 unit dose cups of 15 mL"],"how_supplied_table":["<table width=\"65%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr><td><content styleCode=\"bold\">NDC 39328-120-05: NDC 39328-120-50:</content></td><td><content styleCode=\"bold\">5 mL unit dose cup Case contains 50 unit dose cups of 5 mL</content></td></tr><tr><td><content styleCode=\"bold\">NDC 39328-220-15: NDC 39328-220-50:</content></td><td><content styleCode=\"bold\">15 mL unit dose cup Case contains 50 unit dose cups of 15 mL</content></td></tr></tbody></table>"],"id":"b42865b6-223b-461b-aabd-ca548a0339fa","inactive_ingredient":["Inactive Ingredients Chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water and sucrose"],"indications_and_usage":["Uses Relieves occasional constipation (irregularity) Generally causes bowel movement in 6 to 12 hours"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M007"],"brand_name":["Senna","Senna UD"],"generic_name":["SENNOSIDES"],"is_original_packager":[true],"manufacturer_name":["Patrin Pharma, Inc."],"package_ndc":["39328-020-08","39328-120-05","39328-120-50","39328-120-99","39328-220-15","39328-220-50"],"product_ndc":["39328-020","39328-120","39328-220"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["702311"],"spl_id":["b42865b6-223b-461b-aabd-ca548a0339fa"],"spl_set_id":["a9f1ef8d-8700-481f-a709-972bb9d27153"],"substance_name":["SENNOSIDES"],"unii":["3FYP5M0IJX"],"upc":["0339328120054","0339328220150"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label NDC 39328-020-08 Senna Syrup Natural Vegetable Laxative 8.8mg/5 mL Alcohol Free • Dye Free 8 fl. oz (237 mL) PATRIN PHARMA PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label","PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 39328-120-05 Senna Syrup 8.8 mg/5 mL Shake Well For Institutional Use Only See Insert Lot# xxxxxx Exp: yyyy/mm/dd Patrin Pharma Skokie, IL 60076 Rev 03.0124 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label","PRINCIPAL DISPLAY PANEL - 15 mL Cup Label Delivers 15 mL NDC 39328-220-15 Senna Syrup 26.4 mg/15 mL Shake Well For Institutional Use Only See Insert Lot# xxxxxx Exp: mm/dd/yyyy Patrin Pharma Skokie, IL 60076 Rev 02.0823 PRINCIPAL DISPLAY PANEL - 15 mL Cup Label"],"purpose":["Purpose Laxative"],"questions":["Questions Or Comments? Call (800) 936 3088. You may also report serious side effects to this phone number."],"set_id":"a9f1ef8d-8700-481f-a709-972bb9d27153","spl_product_data_elements":["Senna Sennosides Sennosides Sennosides methylparaben propylene glycol propylparaben water sucrose Senna UD Sennosides Sennosides Sennosides methylparaben propylene glycol propylparaben water sucrose Senna UD Sennosides Sennosides Sennosides methylparaben propylene glycol propylparaben water sucrose"],"spl_unclassified_section":["Drug Facts","Patrin Pharma Skokie, IL 60076 www.patrinpharma.com Rev 01.0122"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use."],"storage_and_handling":["Other Information Store at controlled room temperature 20-25°C (68-77°F). Excursions permitted 15-30°C (59-86°F). Tamper-Evident: Do not use if foil seal over cup is torn or broken."],"version":"1","warnings":["Warnings Do not use laxative products for longer than one week unless directed by a doctor. Ask a doctor before use if you have stomach pain, nausea or vomiting notice a change in bowel habits that last over two weeks are pregnant or breast feeding Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."]}