{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Kroger Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to line)" ], "purpose": [ "Purpose Osmotic Laxative" ], "indications_and_usage": [ "Use relieves occasional constipation /irregularity generally produces a bowel movement in 1 to 3 days" ], "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." ], "do_not_use": [ "Do not use if you have kidney disease, except under the advice and supervision of a doctor" ], "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" ], "when_using": [ "When using this product you may have loose, watery, more frequent stools" ], "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" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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." ], "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" ], "storage_and_handling": [ "Other information store at 20°-25°C (68°-77°F)" ], "inactive_ingredient": [ "Inactive ingredients none" ], "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" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL *Compare to the Active Ingredient in MiraLAX® NDC 30142-526-30 Polyethylene Glycol 3350 , Powder for Solution , Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool UNFLAVORED POWDER 30 ONCE-DAILY DOSES NET WT 17.9 OZ (510g) Dissolves in ANY Beverage *This product is not manufactured or distributed by Bayer HealthCare LLC, the distributer of MiraLAX® Kroger Polyethylene Glycol3350 30 Once Daily Doses", "Principal Display Panel *Compare to the Active Ingredient in MiraLAX® NDC 30142-526-07 Polyethylene Glycol 3350 , Powder for Solution , Osmotic Laxative Relieves Occasional Constipation/Irregularity Softens Stool UNFLAVORED POWDER 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119g) Kroger Polyethylene Glycol3350 7 Once Daily Doses" ], "set_id": "c56271ff-703a-40c4-840f-1962798c9e42", "id": "5a7d8101-1c89-68db-e063-6394a90a84e2", "effective_time": "20260902", "version": "5", "openfda": { "application_number": [ "ANDA202071" ], "brand_name": [ "Kroger" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "KROGER COMPANY" ], "product_ndc": [ "30142-526" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350" ], "rxcui": [ "876193" ], "spl_id": [ "5a7d8101-1c89-68db-e063-6394a90a84e2" ], "spl_set_id": [ "c56271ff-703a-40c4-840f-1962798c9e42" ], "package_ndc": [ "30142-526-30", "30142-526-07" ], "is_original_packager": [ true ], "upc": [ "0041260017506", "0041260017513" ], "nui": [ "N0000010288", "N0000175811", "N0000009871" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P" ] } } ] }