{"active_ingredient":["Drug Facts Active ingredient (in each dose) Polyethylene Glycol 3350, USP 17 grams"],"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":"20260423","id":"048ca2e6-2e71-49f6-81b5-0e34a8f36b77","inactive_ingredient":["Inactive ingredients none Questions or comments? call 1-855-274-4122 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 Made in India Code: TS/DRUGS/16/2014"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA209017"],"brand_name":["POLYETHYLENE GLYCOL 3350"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"is_original_packager":[true],"manufacturer_name":["CARDINAL HEALTH 110, LLC. DBA LEADER"],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["70000-0699-1","70000-0699-2"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["70000-0699"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["048ca2e6-2e71-49f6-81b5-0e34a8f36b77"],"spl_set_id":["04cc4f2e-1725-4710-8cfb-73a6bdf52e4f"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label LEADER TM NDC 70000-0699-1 Grit-Free | Unflavored Powder Packet Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Sugar-Free Dissolves in any Beverage COMPARE TO MiraLAX ® active ingredient* 100% Money Back Guarantee 1 DOSE NET WT 0.5 OZ (17g) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label LEADER TM NDC 70000-0699-2 Grit-Free | Unflavored Powder Packets Polyethylene Glycol 3350 Powder for Oral Solution | Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Sugar-Free Dissolves in Any Beverage COMPARE TO MiraLAX ® active ingredient* 100% Money Back Guarantee 10 PRE-MEASURED, SINGLE DOSES 10 PACKETS 10 ONCE-DAILY DOSES NET WT 0.5 OZ (17g) EACH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Pouch Carton Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"set_id":"04cc4f2e-1725-4710-8cfb-73a6bdf52e4f","spl_product_data_elements":["POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350"],"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"],"storage_and_handling":["Other information store at 20° to 25°C (68° to 77°F) tamper-evident: do not use if foil is open or broken"],"version":"5","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"]}