{ "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": "2026-09-25", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "MiraLAX Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution MiraLAX Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution MiraLAX Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 Colorless upon dissolution MiraLAX Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 colorless upon dissolution" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each dose) (Bottle Only) Polyethylene Glycol 3350, 17 g (cap filled to line)", "Active ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g" ], "purpose": [ "Purpose Osmotic Laxative", "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 you 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 you 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 (Bottle Only) 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", "Directions (Packet Only) do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve one packet of powder (17 g) 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" ], "storage_and_handling": [ "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" ], "inactive_ingredient": [ "Inactive ingredients none" ], "questions": [ "Questions or comments? 1-800-MiraLAX (1-800-647-2529)" ], "recent_major_changes": [ "" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 17 g × 20 Packet Carton 20 Single Doses #1 DOCTOR RECOMMENDED BRAND MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative Mix-In Pax ® Relieves Occasional Constipation/Irregularity Softens Stool 20 ONCE-DAILY DOSES Bayer Unflavored Powder Dissolves in ANY Beverage! UNFLAVORED POWDER GRIT FREE 20 PACKETS NET WT 0.5 OZ (17g) EACH 20ct Carton", "PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton 10 Single Doses #1 DOCTOR RECOMMENDED BRAND MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative Mix-In Pax ® Relieves Occasional Constipation/Irregularity Softens Stool 10 ONCE-DAILY DOSES Bayer Unflavored Powder Dissolves in ANY Beverage! UNFLAVORED POWDER GRIT FREE 10 PACKETS NET WT 0.5 OZ (17g) EACH 10ct Carton", "PRINCIPAL DISPLAY PANEL - 30 Dose (510 g) Bottle Label Easy to Pour Bottle #1 DOCTOR RECOMMENDED BRAND MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative UNFLAVORED POWDER GRIT FREE Relieves Occasional Constipation/Irregularity Softens Stool Bayer 30 ONCE-DAILY DOSES NET WT 17.9 OZ (510 g) 30 Front 30 Dose - Back", "PRINCIPAL DISPLAY PANEL - Twinpack 2x34 Dose (578 g) Bottle Label Twin Pack! 2 x 34 Doses Easy to Pour Bottle MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative #1 DOCTOR RECOMMENDED BRAND Relieves Occasional Constipation/Irregularity Softens Stool UNFLAVORED POWDER GRIT FREE Bayer 34 ONCE-DAILY DOSES NET WT 20.4 OZ (578 g) 34 Dose Front 34 Dose Back" ], "set_id": "d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "id": "51040c1b-71bf-bb83-e063-6294a90aca4e", "effective_time": "20260504", "version": "24", "openfda": { "application_number": [ "NDA022015" ], "brand_name": [ "MiraLAX" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "Bayer HealthCare LLC." ], "product_ndc": [ "11523-4357", "11523-7268", "11523-7234", "11523-7341" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350" ], "rxcui": [ "876193", "876195" ], "spl_id": [ "51040c1b-71bf-bb83-e063-6294a90aca4e" ], "spl_set_id": [ "d69ce3d4-7ca4-4fe3-b49e-6655e48d6963" ], "package_ndc": [ "11523-7268-3", "11523-7268-8", "11523-7268-7", "11523-7268-4", "11523-7268-9", "11523-7268-5", "11523-7234-1", "11523-7234-2", "11523-7234-3", "11523-7234-4", "11523-7234-5", "11523-7234-6", "11523-7234-9", "11523-7341-1", "11523-7341-2", "11523-4357-1", "11523-4357-3", "11523-4357-5", "11523-4357-2" ], "is_original_packager": [ true ], "upc": [ "0041100820716", "0041100564542" ], "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" ] } } ] }