{"active_ingredient":["Active Ingredient (in each dose) Polyethylene Glycol 3350 USP, 17g"],"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 years of age and older: use once a day stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners 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":"20250219","id":"2e7e711f-65c3-a4b4-e063-6294a90a85ef","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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA202850"],"brand_name":["Polyethylene Glycol 3350"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"is_original_packager":[true],"manufacturer_name":["NorthStar Rx LLC"],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["72603-302-01","72603-302-04","72603-302-03","72603-302-02"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["72603-302"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["2e7e711f-65c3-a4b4-e063-6294a90a85ef"],"spl_set_id":["2e7e72eb-b759-5b59-e063-6394a90aa7ff"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 72603-302-04 Polyethylene Glycol 3350 Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Dissolves in any Beverage Sugar free 100 Once-Daily Doses 100 Packets NET WT 0.5 oz (17 g) Each 100 Single Doses Compare to MiraLAX ® Active Ingredient Polyethylene_Glycol_3350_17g_100"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"questions":["Questions or comments? 1-800-206-7821"],"recent_major_changes":["Carton-100pkt"],"set_id":"2e7e72eb-b759-5b59-e063-6394a90aa7ff","spl_product_data_elements":["Polyethylene Glycol 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350"],"spl_unclassified_section":["Other information store at 20° to 25°C (68° to 77°F) tamper-evident: do not use if printed foil pouch is open or broken","Packaged for: NorthStar Rx LLC Memphis, TN 38141 Packaged by: Novitium Pharma LLC East Windsor, NJ 08520 Rev 01/2025"],"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 get diarrhea you need to use a laxative for longer than 1 week"],"version":"1","warnings":["Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol"],"when_using":["When using this product you may have loose, watery, more frequent stools"]}