{"active_ingredient":["Active ingredient (in each dose) Polyethylene 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 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":"20260910","id":"41972e0f-61cb-43d5-a74e-f10ee85dcfe8","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":["ANDA217505"],"brand_name":["Polyethylene Glycol 3350"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"is_original_packager":[true],"manufacturer_name":["L.N.K. International, Inc."],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["50844-772-43","50844-772-03","50844-772-48","50844-772-09","50844-772-01","50844-772-12","50844-772-92","50844-772-49","50844-772-90","50844-772-93"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["50844-772"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["41972e0f-61cb-43d5-a74e-f10ee85dcfe8"],"spl_set_id":["bbc11078-73f7-4d27-b0d3-4d4ae5dae240"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"],"upc":["0350844772039"]},"package_label_principal_display_panel":["Principal display panel QUALITY +PLUS NDC 50844-772-03 *Compare to active ingredient in MiraLAX® Polyethylene Glycol 3350 Powder for Solution OSMOTIC LAXATIVE • Relieves occasional constipation/irregularity • Softens stool • Dissolves in any beverage • Sugar free • Unflavored • Grit free 10 Once-Daily Doses 10 PACKETS NET WT 0.5 OZ (17 g) EACHS Quality Plus 44-772 Quality Plus 44-772"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"questions":["Questions or comments? Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday"],"set_id":"bbc11078-73f7-4d27-b0d3-4d4ae5dae240","spl_product_data_elements":["Polyethylene Glycol 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 colorless upon dissolution"],"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°-25°C (68°-77°F) tamper-evident: do not use if foil is open or broken"],"version":"10","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 get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of 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"]}