{"active_ingredient":["Drug Facts Active ingredient (in each dose) Polyethylene Glycol 3350, USP 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 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 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 (17g) 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":"20260423","id":"0ae015fc-a1b3-4ace-b5de-85e07b154f5c","inactive_ingredient":["Inactive ingredients none Questions or comments? call 1-855-274-4122 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 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":["Aurobindo Pharma Limited"],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["84386-125-08","84386-125-24","84386-125-54","84386-125-14"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["84386-125"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["0ae015fc-a1b3-4ace-b5de-85e07b154f5c"],"spl_set_id":["b51f2223-8266-4d6c-bf32-58e53e73b54d"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"],"upc":["0384386125084"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label AUROBINDO NDC 84386-125-08 Compare to active ingredient of MiraLax ® * Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool UNFLAVORED POWDER - GRIT FREE 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 119 g Bottle Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label Compare to active ingredient of MiraLax ® * Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool Sugar Free Dissolves in any Beverage UNFLAVORED POWDER - GRIT FREE 1 DOSE NET WT 0.5 oz (17 g) fig","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Carton Label AUROBINDO NDC 84386-125-14 Compare to active ingredient of MiraLax ® * Polyethylene Glycol 3350 Powder for Oral Solution Osmotic Laxative Polyethylene Glycol 3350 powder for oral solution increases frequency of bowel movements and softness the stool. Relieves Occasional Constipation/Irregularity Softens Stool Sugar Free Dissolves in Any Beverage 14 ONCE-DAILY DOSES UNFLAVORED POWDER - GRIT FREE 14 PRE-MEASURED, SINGLE DOSES 14 Packets NET WT 0.5 oz (17 g Each) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 17 g Sachet Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"set_id":"b51f2223-8266-4d6c-bf32-58e53e73b54d","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 seal under cap, printed with \"SEALED for YOUR PROTECTION\" is missing, open or broken"],"version":"2","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"]}