{ "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": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 116 } }, "results": [ { "spl_product_data_elements": [ "purelax Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350" ], "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 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 (1-800-222-1222)." ], "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 or 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, 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "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 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 powder is fully dissolved before drinking • do no 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) • tamper-evident: do not use if printed foil seal under cap is missing, open or broken" ], "inactive_ingredient": [ "Inactive ingredients none" ], "questions": [ "Questions or comments? 1-800-719-9260" ], "package_label_principal_display_panel": [ "Principal Display Panel CVS Health ® Compare to the active ingredient in MiraLAX ® Purelax ® POLYETHYLENE GLYCOL 3350 Powder for solution, Osmotic laxative UNFLAVORED POWDER – GRIT FREE • Relieves occasional constipation / irregularity • Softens stool NET WT 17.9 OZ (510 g) 30 Once-daily Doses purelax-image" ], "set_id": "006a9eca-400f-47f5-bee5-facf7034043e", "id": "058dfc70-1941-42dc-af01-f382a60d8f77", "effective_time": "20250321", "version": "15", "openfda": { "application_number": [ "ANDA090685" ], "brand_name": [ "purelax" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "CVS Pharmacy" ], "product_ndc": [ "59779-306" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350" ], "rxcui": [ "876193", "1010732" ], "spl_id": [ "058dfc70-1941-42dc-af01-f382a60d8f77" ], "spl_set_id": [ "006a9eca-400f-47f5-bee5-facf7034043e" ], "package_ndc": [ "59779-306-01", "59779-306-02", "59779-306-03", "59779-306-04", "59779-306-53", "59779-306-18", "59779-306-17", "59779-306-19", "59779-306-52", "59779-306-60", "59779-306-09" ], "is_original_packager": [ true ], "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" ] } } ] }