{"active_ingredient":["Active ingredients & Purpose 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":["
Active ingredients (in each 59 ml delivered dose)Purpose
Dibasic Sodium Phosphate 3.5g.....Saline laxative
Monobasic Sodium Phosphate 9.5g.....Saline laxative
"],"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 of age Use 1 bottle once daily children under 2 years of age DO NOT USE"],"dosage_and_administration_table":["
children 2 to under 12 years of ageUse 1 bottle once daily
children under 2 years of ageDO NOT USE
"],"effective_time":"20241119","id":"274788d7-9fec-5b62-e063-6294a90ad899","inactive_ingredient":["Inactive ingredients benzalkonium chloride, disodium EDTA, purified water"],"indications_and_usage":["Uses 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":{"application_number":["M007"],"brand_name":["REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE"],"generic_name":["SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM"],"is_original_packager":[true],"manufacturer_name":["Leosons Overseas Corp"],"package_ndc":["69626-0085-7"],"product_ndc":["69626-0085"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["283100"],"spl_id":["274788d7-9fec-5b62-e063-6294a90ad899"],"spl_set_id":["90e7c2b4-35e1-4a27-afea-9257c480e190"],"substance_name":["SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM","SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM"],"unii":["GR686LBA74","3980JIH2SW"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 69626-0085-7 RELIEF ™ SALINE LAXATIVE Pediatric Ready-to-Use ENEMA For relief of occasional constipation Pre-Mixed Not Made With Natural Rubber Latex Ages 2-11 Lubricated Tip 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":["
Active ingredients (in each 59 ml delivered dose)Purpose
Dibasic Sodium Phosphate 3.5g.....Saline laxative
Monobasic Sodium Phosphate 9.5g.....Saline laxative
"],"questions":["Questions or comments? Call toll-free at +1-855-452-9500 or email info@Leosonsintl.com"],"set_id":"90e7c2b4-35e1-4a27-afea-9257c480e190","spl_product_data_elements":["REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION"],"spl_unclassified_section":["Drug Facts Drug Facts","Distributed by: Leosons 10 Maryland Avenue Albany, New York 12205"],"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"]}