{"active_ingredient":["Active ingredient (in each 118 mL delivered dose) Mineral oil 100%"],"ask_doctor":["Ask a doctor before use if you have abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your doctor"],"dosage_and_administration":["Directions Single daily dose (per 24 hours). adults & children 12 years and over 1 bottle once daily children 2 to under 12 years 1/2 bottle once daily discard unused portion children under 2 years DO NOT USE"],"dosage_and_administration_table":["<table width=\"50%\" styleCode=\"Noautorules\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"center\" valign=\"middle\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults &amp; children 12 years and over</td><td>1 bottle once daily</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 2 to under 12 years</td><td align=\"left\">1/2 bottle once daily discard unused portion</td></tr><tr><td styleCode=\"Rrule\">children under 2 years</td><td>DO NOT USE</td></tr></tbody></table>"],"effective_time":"20250929","id":"c0bcd9e0-55c5-441d-a847-d77cec1c1972","inactive_ingredient":["Inactive ingredients none"],"indications_and_usage":["Uses for relief of occasional constipation for relief of fecal impaction for removal of residue after barium administration"],"keep_out_of_reach_of_children":["Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"openfda":{"application_number":["M007"],"brand_name":["Leader Ready to Use Mineral Oil Laxative"],"generic_name":["MINERAL OIL"],"is_original_packager":[true],"manufacturer_name":["Cardinal Health"],"package_ndc":["70000-0109-1"],"product_ndc":["70000-0109"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["205121"],"spl_id":["c0bcd9e0-55c5-441d-a847-d77cec1c1972"],"spl_set_id":["b8494d02-8a7d-47b4-80b0-b8ab51b625fd"],"substance_name":["MINERAL OIL"],"unii":["T5L8T28FGP"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton LEADER ™ NDC 70000-0109-1 Ready-To-Use Enema Mineral Oil Lubricant Laxative Sodium Free For Relief Of: Occasional Constipation Comfortable, Lubricated Tip Works in Minutes Not Made With Natural Rubber Latex COMPARE TO FLEET ® MINERAL OIL ENEMA active ingredient* 1 BOTTLE 100% Money Back Guarantee 4 .5 FL OZ (133 mL) PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Purpose Lubricant laxative"],"questions":["Questions or comments? 1-866-323-0107"],"set_id":"b8494d02-8a7d-47b4-80b0-b8ab51b625fd","spl_product_data_elements":["Leader Ready to Use Mineral Oil Laxative mineral oil MINERAL OIL MINERAL OIL"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition."],"storage_and_handling":["Other information store at 15°-30°C (59°-86°F) this product generally produces a bowel movement in 2 to 15 minutes"],"version":"6","warnings":["Warnings For rectal use only Ask a doctor before use if you have abdominal pain, nausea, or vomiting if you have a sudden change in bowel habits that persists over a period of 2 weeks if you have already used a laxative for more than 1 week if constipation continues after one week of use, contact your doctor Stop use and ask a doctor if you have rectal bleeding or no bowel movement within 15 minutes of using this product you need to use a laxative for more than one week These symptoms may indicate a serious condition. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}