{"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":"20260619","id":"7f3bcd03-92c9-4221-a9f7-133ebfcb49e0","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":["ANDA203928"],"brand_name":["Polyethylene glycol 3350"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"manufacturer_name":["Cardinal Health 107, LLC"],"nui":["N0000010288","N0000175811","N0000009871"],"original_packager_product_ndc":["0904-6931"],"package_ndc":["55154-8091-5"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["55154-8091"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["7f3bcd03-92c9-4221-a9f7-133ebfcb49e0"],"spl_set_id":["4e8b6a32-11ec-4419-9ec8-aaa182389972"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"],"upc":["0055154809153"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-8091-5 PEG3350 Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 5-Packets NET WT 0.5 OZ (17 g) EACH 100% bag label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"questions":["Questions or comments? 1-800-616-2471"],"set_id":"4e8b6a32-11ec-4419-9ec8-aaa182389972","spl_product_data_elements":["Polyethylene glycol 3350 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 colorless upon dissolution"],"spl_unclassified_section":[". TAMPER-EVIDENT: DO NOT USE IF FOIL IS OPEN OR BROKEN *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark MiraLAX®. Distributed by MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 www.majorpharmaceuticals.com Overbagged with 10 packets per bag, NDC 55154-8091-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed By: Cardinal Health Dublin, OH 43017 L56118351223 Rev. 03/22 M-17 Re-order No. 701066 Product of India 50844 REV0222D72648"],"stop_use":["Stop use and ask a doctor if ▪ you get diarrhea ▪ you need to use a laxative for longer than 1 week ▪ you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition."],"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":"5","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 get diarrhea ▪ you need to use a laxative for longer than 1 week ▪ you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. 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"]}