{"active_ingredient":["Active ingredient (in each dose) Polyethylene Glycol 3350, 17 grams (cap filled to the indicated line)"],"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 (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with the 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":"20221028","id":"f0c44850-fe07-4c48-bb9c-ded2c7fb822b","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 childreen 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"],"is_original_packager":[true],"manufacturer_name":["Gericare Pharmaceuticals"],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["57896-490-07","57896-490-14","57896-490-30","57896-490-45","57896-490-01","57896-490-03"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["57896-490"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193"],"spl_id":["f0c44850-fe07-4c48-bb9c-ded2c7fb822b"],"spl_set_id":["5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"]},"other_safety_information":["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"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Original Prescription Strength Polyethylene Glycol 3350 Powder for Solution Osmotic Laxative Relieves Occasional Constipation (Irregularity) Softens Stool TAMPER-EVIDENT: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS MISSING, OPEN OR BROKEN Dissolves in any beverage Sugar Free NDC 57896-490-01 1 DOSE NET WT 0.5 OZ (17 g) NDC 57896-490-03 30 PACKETS NET WT 0.5 OZ (17 g) Each NDC 57896-490-07 7 ONCE-DAILY DOSES NET WT 4.15 OZ (119 g) NDC 57896-490-14 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) NDC 57896-490-30 30 ONCE-DAILY DOSES NET WT 17.9 OZ (510 g) NDC 57896-490-45 45 ONCE-DAILY DOSES NET WT 26.9 OZ (765 g) 17g sachet 30s carton 119g bottle 238g bottle 510g 765g bottle"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Osmotic Laxative"],"questions":["Questions or comments? 1-800-540-3765 Manufactured for: Geri-Care Pharmaceuticals 1295 Townbin Ave. Lakewood, NJ 08701 Product of India Issued: 07/2022"],"set_id":"5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd","spl_product_data_elements":["Polyethylene Glycol 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution"],"spl_unclassified_section":["Drug Facts"],"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 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 childreen 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"]}