{"active_ingredient":["Active ingredients (in each 59 ml delivered dose) Purpose Dibasic Sodium Phosphate 3.5g Saline laxative Monobasic Sodium Phosphate 9.5g Saline laxative"],"active_ingredient_table":["<table width=\"65%\"> <col width=\"60%\" align=\"left\" valign=\"bottom\"/> <col width=\"40%\" align=\"right\" valign=\"bottom\"/> <thead> <tr> <th styleCode=\"italics\">Active ingredients (in each 59 ml delivered dose)</th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Dibasic Sodium Phosphate 3.5g</td> <td>Saline laxative</td> </tr> <tr> <td>Monobasic Sodium Phosphate 9.5g</td> <td>Saline laxative</td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if the child has already used a laxative for more than 3 days has kidney disease, have heart problems, or are dehydrated is on a sodium-restricted diet has abdominal pain, nausea, or vomiting has a sudden change in bowel habits lasting more than 2 weeks"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the child is taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work."],"do_not_use":["Do not use on children under 2 years of age"],"dosage_and_administration":["Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings . children 2 to under 12 years old 1 bottle once daily children under 2 years DO NOT USE"],"dosage_and_administration_table":["<table width=\"50%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"center\" valign=\"middle\"/> <col width=\"50%\" align=\"center\" valign=\"middle\"/> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">children 2 to under 12 years old</td> <td>1 bottle once daily</td> </tr> <tr> <td styleCode=\"Rrule\">children under 2 years</td> <td>DO NOT USE</td> </tr> </tbody> </table>"],"effective_time":"20180524","id":"c75f4dd4-e4a6-49b4-94df-0979b152fcdb","inactive_ingredient":["Inactive ingredients benzalkonium chloride, disodium EDTA, purified water"],"indications_and_usage":["Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton Natureplex™ pediatric ages 2-11 NDC 67234-042-01 ENEMA *Compare To Fleet ® saline laxative Not Made with Natural Rubber Latex Pre-mixed For relief of occasional constipation Pre-lubricated tip 1 Bottle 2.25 Fl Oz (67 mL) PRINCIPAL DISPLAY PANEL - 67 mL Bottle Carton"],"purpose":["Active ingredients (in each 59 ml delivered dose) Purpose Dibasic Sodium Phosphate 3.5g Saline laxative Monobasic Sodium Phosphate 9.5g Saline laxative"],"purpose_table":["<table width=\"65%\"> <col width=\"60%\" align=\"left\" valign=\"bottom\"/> <col width=\"40%\" align=\"right\" valign=\"bottom\"/> <thead> <tr> <th styleCode=\"italics\">Active ingredients (in each 59 ml delivered dose)</th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Dibasic Sodium Phosphate 3.5g</td> <td>Saline laxative</td> </tr> <tr> <td>Monobasic Sodium Phosphate 9.5g</td> <td>Saline laxative</td> </tr> </tbody> </table>"],"questions":["Questions or comments? 866-323-0107 or www.natureplex.com"],"set_id":"267f80dd-2304-4632-9620-f54fd807da82","spl_product_data_elements":["Pediatric Saline Laxative SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, DIBASIC SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if the child has rectal bleeding has no bowel movement within 30 minutes of enema use has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition."],"storage_and_handling":["Other information each 59 mL contains 2.2g sodium store at 15 to 30°C (59 to 86°F) additional liquids by mouth are recommended while using this product Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING."],"version":"3","warnings":["Warnings For rectal use only. Dosage warning Using more than one enema in 24 hours can be harmful. Do not use on children under 2 years of age Ask a doctor before use if the child has already used a laxative for more than 3 days has kidney disease, have heart problems, or are dehydrated is on a sodium-restricted diet has abdominal pain, nausea, or vomiting has a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if the child is taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if the child has rectal bleeding has no bowel movement within 30 minutes of enema use has symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222."],"when_using":["When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor"]}