{"active_ingredient":["Active ingredient (in each dose) Polyethlene Glycol 3350, 17 g"],"ask_doctor":["Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug"],"do_not_use":["Do not use if you have kidney disease, except under the advice and supervision of a doctor"],"dosage_and_administration":["Directions do not take more than directed unless advised by your doctor adults and children 17 yearsof age and older: use once a day stir and dissolve one packet of powder (17 g) in any 4 to 8 ounce of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor"],"effective_time":"20250612","id":"3765aba8-f541-9e31-e063-6394a90a80eb","inactive_ingredient":["Inactive ingredients none"],"indications_and_usage":["Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days"],"keep_out_of_reach_of_children":["Keep out of the reach of children."],"openfda":{"application_number":["ANDA203928"],"brand_name":["Polyethylene Glycol 3350"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"manufacturer_name":["Kesin Pharma Corporation"],"nui":["N0000010288","N0000175811","N0000009871"],"original_packager_product_ndc":["59556-762"],"package_ndc":["81033-762-17","81033-762-14","81033-762-30","81033-762-01"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["81033-762"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["3765aba8-f541-9e31-e063-6394a90a80eb"],"spl_set_id":["3729a1d2-4c98-dfdf-e063-6394a90a5a87"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"]},"other_safety_information":["Other information store at 20°C to 25°C (68°F to 77°F) tamper-evident: do not use if printed foil pouch is open or broken this package is not child-resistant"],"overdosage":["In case of overdose, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 81033-762-14 Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative 14 Packets (14 once-daily-doses) PEG3350Powder_14count_Carton","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 81033-762-30 Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative 30 Packets (30 once-daily doses) PEG3350Powder_30count_Carton","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 81033-762-01 Polyethylene Glycol 3350 Powder for Oral Solution Osmotic laxative 100 Packets (100 once-daily doses) PEG3350Powder_100count_Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"questions":["Questions or comments? Call 1-833-537-4679"],"set_id":"3729a1d2-4c98-dfdf-e063-6394a90a5a87","spl_product_data_elements":["Polyethylene Glycol 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution"],"spl_unclassified_section":["Polyethylene Glycol 3350 increases frequency of bowel movements and softens stools Drug Facts","TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN *This product is not manufactured by Bay HealthCare LLC, owner of the registered trademark MiraLAX ® Distributed by: Kesin Pharma Oldsmar, FL 34677 Kesin Pharma Logo"],"spl_unclassified_section_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL POUCH IS OPEN OR BROKEN</content></td></tr></tbody></table>"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you need to use a laxative for longer than 1 week you get diarrhea"],"version":"2","warnings":["Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you need to use a laxative for longer than 1 week you get diarrhea 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 you may have loose, watery, more frequent stools"]}