{"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 ▪ 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 no more than 7 days ▪ children 16 years of age or under : ask a doctor"],"effective_time":"20250410","id":"57a2d3da-388a-437e-9ea3-9e3aef12a0df","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. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA202071"],"brand_name":["Winco"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"is_original_packager":[true],"manufacturer_name":["WINCO FOODS"],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["67091-447-08"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["67091-447"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["57a2d3da-388a-437e-9ea3-9e3aef12a0df"],"spl_set_id":["d649f758-a46f-4864-8718-878ee5a74bfc"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL *Compare to the active ingredient in MiraLAX® NDC 67091-447-08 Polyethylene Glycol 3350 , Powder for Solution , Osmotic Laxative • Relieves Occasional Constipation/Irregularity • Softens Stool UNFLAVORED POWDER 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) • Dissolves in Any Beverage DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID, 83704 *This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX® WINCO Polyethelene Glycol3350 14 Once daily Doses"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"questions":["Questions or comments? 1-866-467-2748 TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH \"SEALED FOR YOUR PROTECTION\" IS MISSING, OPEN OR BROKEN"],"set_id":"d649f758-a46f-4864-8718-878ee5a74bfc","spl_product_data_elements":["Winco Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if • you have rectal bleeding or your 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)"],"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 your 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."],"when_using":["When using this product you may have loose, watery, more frequent stools"]}