{"active_ingredient":["Active I ngredient (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 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 Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022"],"dosage_and_administration":["Directions d o 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 the 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":"20240117","id":"fc3454ec-7729-4327-90f7-9e12dddb19d6","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":["ANDA090812"],"brand_name":["Polyethylene Glycol 3350, NF Powder for Solution, Laxative"],"generic_name":["POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE"],"is_original_packager":[true],"manufacturer_name":["LGM PHARMA SOLUTIONS, LLC"],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["79739-7116-1","79739-7116-2","79739-7116-3"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["79739-7116"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["fc3454ec-7729-4327-90f7-9e12dddb19d6"],"spl_set_id":["d78bead5-ff19-4d45-9003-ec131f1f5a13"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"]},"package_label_principal_display_panel":["Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Relives Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free Net Wt. 4.1 OZ ( 119 g) 7 ONCE-DAILY DOSES NDC: 79739-7116- 1 LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free Net Wt. 4.1 OZ (119g) 7 ONCE-DAILY DOSES NDC: 79739-7116-1","Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Reli e ves Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free NDC: 79739-7116-2 Net Wt. 8.3 OZ ( 238 g) 14 ONCE-DAILY DOSES LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free NDC: 79739-7116-2 Net Wt. 8.3 OZ (238g) 14 ONCE-DAILY DOSES","Principal Display Panel LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative Relives Occasional Constipation/ I rregularity Softens Stool Unflavored Powder Sugar Free NDC: 79739-7116-3 Net Wt. 17.9 OZ (510g) 30 ONCE-DAILY DOSES LGM PHARMA SOLUTIONS, LLC PRODUCT: Polyethylene Glycol 3350, NF Powder for Solution, Osmotic Laxative o Relives Occasional Constipation/irregularity o Softens Stool o Unflavored Powder o Sugar Free NDC: 79739-7116-3 Net Wt. 17.9 OZ (510g) 30 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 c omments? 1-877-288-1495 Polyethylene Glycol 3350, NF increases frequency of bowel movements and softens the stool."],"set_id":"d78bead5-ff19-4d45-9003-ec131f1f5a13","spl_product_data_elements":["Polyethylene Glycol 3350, NF Powder for Solution, Laxative Polyethylene Glycol 3350, NF Powder for Solution, Laxative POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 colorless upon dissolution"],"spl_unclassified_section":["Drug Facts","Other Information store at 20° – 25°C (68° – 77°F) tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken"],"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"],"version":"4","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 Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 7116-0 119 -99- EC -PD Rev. 01/2022 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"]}