{"active_ingredient":["Active Ingredient Polyethylene Glycol 3350, 17 g (cap filled to line)……………………Osmotic Laxative"],"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 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"],"dosage_and_administration":["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."],"effective_time":"20251208","id":"ced29c35-5d51-4eb1-8119-1c988d29a592","inactive_ingredient":["Inactive Ingredient none"],"indications_and_usage":["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. adults and children 17 years of age and older: use once a day fill to top of line 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 more than 7 days children 16 years of age or under: ask a doctor Other Information store at 20°- 25°C (68°– 77°F) tamper-evident: do not use if printed foil seal under cap, printed with \"SEALED for YOUR PROTECTION\" is missing, open or broken"],"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. (1-800-222-1222)"],"openfda":{"application_number":["ANDA091077"],"brand_name":["GAVILAX"],"generic_name":["POLYETHYLENE GLYCOL 3350"],"is_original_packager":[true],"manufacturer_name":["Lupin Pharmaceuticals,Inc."],"nui":["N0000010288","N0000175811","N0000009871"],"package_ndc":["43386-312-14","43386-312-08","43386-312-07","43386-312-85"],"pharm_class_epc":["Osmotic Laxative [EPC]"],"pharm_class_moa":["Osmotic Activity [MoA]"],"pharm_class_pe":["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"],"product_ndc":["43386-312"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["876193","876214"],"spl_id":["ced29c35-5d51-4eb1-8119-1c988d29a592"],"spl_set_id":["19672e23-1606-497e-a112-939af33af195"],"substance_name":["POLYETHYLENE GLYCOL 3350"],"unii":["G2M7P15E5P"],"upc":["0343386312085"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 43386-312-08 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 14 ONCE-DAILY DOSES NET WT 8.3 OZ (238 g) NDC 43386-312-85 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 50 ONCE-DAILY DOSES NET WT 29.9 OZ (850 g) NDC 43386-312-07 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 7 ONCE-DAILY DOSES NET WT 4.1 OZ (119 g) NDC 43386-312-14 Original Prescription Strength GaviLax Polyethylene Glycol 3350 Powder for Oral Solution, Osmotic Laxative 30 ONCE-DAILY DOSES NET WT 17.9 OZ (510 g) 238g Drug facts- back 238 g 850 g 4.1 oz 119 g back 17.9 oz"],"purpose":["Purpose Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days"],"questions":["Questions or comments? 1-866-403-7592 Dissolves in any beverages Sugar Free"],"set_id":"19672e23-1606-497e-a112-939af33af195","spl_product_data_elements":["GAVILAX Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 SODIUM HYDROXIDE"],"version":"8","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"]}