{"active_ingredient":["Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)"],"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 of 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 (Bottle Only) do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17 g) stir and dissolve 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":"20251204","id":"4526ca58-f032-31ad-e063-6394a90a7bae","inactive_ingredient":["Inactive ingredients natural and artificial orange flavor, sucralose"],"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. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222)."],"openfda":{"application_number":["ANDA090685"],"brand_name":["MiraLAX Orange Flavor"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"is_original_packager":[true],"manufacturer_name":["Bayer HealthCare LLC."],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["11523-0122-2","11523-0122-1"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["11523-0122"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193","876195"],"spl_id":["4526ca58-f032-31ad-e063-6394a90a7bae"],"spl_set_id":["0a5b2121-928f-8f49-e063-6394a90a8aaf"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"],"upc":["0041100600554"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 7 Dose Bottle MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Grit-Free Powder Sugar-Free & Dye-Free ORANGE FLAVOR 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g) Bayer PDP PDP MiraLAX Orange 7 dose Front Label"],"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-MiraLAX (1-800-647-2529)"],"set_id":"0a5b2121-928f-8f49-e063-6394a90a8aaf","spl_product_data_elements":["MiraLAX Orange Flavor Polyethylene Glycol 3350 SUCRALOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 White or almost white solid with a waxy or paraffin-like appearance"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or 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 printed foil seal under cap is missing, open or broken"],"version":"3","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 of 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 you nausea, bloating or 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1-800-222-1222)."],"when_using":["When using this product you may have loose, watery, more frequent stools"]}