{"active_ingredient":["Active ingredients (in each 118 mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative"],"active_ingredient_table":["<table width=\"65%\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active ingredients</content> (in each 118 mL delivered dose)</th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Dibasic Sodium Phosphate 7 g</td> <td>Saline laxative</td> </tr> <tr> <td>Monobasic Sodium Phosphate 19 g</td> <td>Saline laxative</td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if you already used a laxative for more than 1 week are dehydrated have kidney disease are 55 years old or older have heart problems are on a sodium-restricted diet","Ask a doctor before using any laxative if you have abdominal pain, nausea, or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week"],"dosage_and_administration":["Directions 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 . Adults and Children 12 years old and older 1 bottle once daily Children 2 to under 12 years old 1/2 bottle once daily Children under 2 years DO NOT USE"],"dosage_and_administration_table":["<table width=\"60%\" styleCode=\"Noautorules\"> <col width=\"50%\" align=\"center\" valign=\"top\"/> <col width=\"50%\" align=\"center\" valign=\"middle\"/> <tbody> <tr styleCode=\"Toprule Botrule\"> <td styleCode=\"Rrule Toprule\">Adults and Children 12 years old and older</td> <td styleCode=\"Toprule\">1 bottle once daily</td> </tr> <tr styleCode=\"Botrule\"> <td styleCode=\"Rrule\">Children 2 to under 12 years old</td> <td>1/2 bottle once daily</td> </tr> <tr> <td styleCode=\"Rrule\">Children under 2 years</td> <td>DO NOT USE</td> </tr> </tbody> </table>"],"effective_time":"20170712","id":"987aa9cc-4f7e-442b-b901-a60597a5ad32","inactive_ingredient":["Inactive ingredients Benzalkonium chloride, disodium EDTA, purified water"],"indications_and_usage":["Use Relieves occasional constipation"],"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."],"openfda":{"application_number":["part334"],"brand_name":["QUALITY CHOICE SINGLE SALINE LAXATIVE"],"generic_name":["SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM"],"is_original_packager":[true],"manufacturer_name":["Alcyon Health, LLC."],"package_ndc":["71443-001-06"],"product_ndc":["71443-001"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["283100"],"spl_id":["987aa9cc-4f7e-442b-b901-a60597a5ad32"],"spl_set_id":["eb499c7f-9c7b-4097-83a3-82aabffd6beb"],"substance_name":["SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM","SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM"],"unii":["GR686LBA74","3980JIH2SW"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton maia medical™ SALINE enema 6 Bottles 4.5 Fl Oz (133 ml) each Latex Free PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 118 mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative"],"purpose_table":["<table width=\"65%\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active ingredients</content> (in each 118 mL delivered dose)</th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Dibasic Sodium Phosphate 7 g</td> <td>Saline laxative</td> </tr> <tr> <td>Monobasic Sodium Phosphate 19 g</td> <td>Saline laxative</td> </tr> </tbody> </table>"],"questions":["Questions or comments? 1-844-624-2633 or www.maiamed.com"],"set_id":"eb499c7f-9c7b-4097-83a3-82aabffd6beb","spl_product_data_elements":["QUALITY CHOICE SINGLE SALINE LAXATIVE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM SODIUM CATION PHOSPHATE ION SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM SODIUM CATION PHOSPHATE ION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER"],"spl_unclassified_section":["Drug Facts","Distributed By: Maia Medical 655 Metro Place South, Suite 600-050 Dublin, OH 43017 USA"],"stop_use":["Stop use and ask a doctor if you have bleeding the condition worsens or does not improve within 7 days you have no bowel movement within 30 minutes of enema use you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition."],"storage_and_handling":["Other information each 118 ml contains 4.4 g sodium store at 15 to 30°C (59 to 86°F) additional liquids by mouth are recommended while using this product this product generally produces a bowel movement in 1 to 5 minutes carton sealed for safety. Do not use if the top or bottom flap of the carton is torn or missing"],"version":"1","warnings":["Warnings For rectal use only Dosage warning Using more than one enema in 24 hours can be harmful. Ask a doctor before use if you already used a laxative for more than 1 week are dehydrated have kidney disease are 55 years old or older have heart problems are on a sodium-restricted diet Ask a doctor before using any laxative if you have abdominal pain, nausea, or vomiting a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week 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 Stop use and ask a doctor if you have bleeding the condition worsens or does not improve within 7 days you have no bowel movement within 30 minutes of enema use you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"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"]}