{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "spl_product_data_elements": [ "Sunmark Saline Single Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER" ], "spl_unclassified_section": [ "Drug Facts", "Distributed By Strategic Sourcing Services LLC 6555 State Highway 161, Irving, TX 75039" ], "active_ingredient": [ "Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative" ], "active_ingredient_table": [ "
Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative
" ], "purpose": [ "Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative" ], "purpose_table": [ "
Active ingredients (in each 118mL delivered dose)Purpose
Dibasic Sodium Phosphate 7 gSaline laxative
Monobasic Sodium Phosphate 19 gSaline laxative
" ], "indications_and_usage": [ "Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes" ], "warnings": [ "Warnings Dosage warning Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are 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 you have rectal bleeding 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: 800-222-1222." ], "do_not_use": [ "Do not use on children under 2 years of age" ], "ask_doctor": [ "Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are 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": [ "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": [ "Stop use and ask a doctor if you have rectal bleeding 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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "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." ], "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 . Adults and children 12 years of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and older1 bottle once daily
Children 2 to under 12 years of ageUse Pediatric Enema
Children under 2 years of ageDO NOT USE
" ], "storage_and_handling": [ "Other information each 118 ml contains sodium 4.3 g 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." ], "inactive_ingredient": [ "Inactive ingredients benzalkonium chloride, disodium EDTA, purified water" ], "questions": [ "Questions or comments? 1-800-633-5463" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton sunmark ® COMPARE TO FLEET® ENEMA SALINE ACTIVE INGREDIENTS* NDC 49348-186-20 complete & ready-to-use enema Saline Laxative For relief of occasional constipation Soft, flexible Comfort tip Pre-mixed LATEX FREE 4.5 FL OZ (133 ml) PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton" ], "set_id": "06720229-7d58-499e-b7de-cb4bda5ae416", "id": "421da116-c4f5-42e6-bfc8-7e31e02c0ae4", "effective_time": "20260108", "version": "5", "openfda": { "application_number": [ "M007" ], "brand_name": [ "Sunmark Saline Single Laxative" ], "generic_name": [ "SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM" ], "manufacturer_name": [ "Strategic Sourcing Services LLC" ], "product_ndc": [ "49348-186" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "RECTAL" ], "substance_name": [ "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM", "SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM" ], "rxcui": [ "283100" ], "spl_id": [ "421da116-c4f5-42e6-bfc8-7e31e02c0ae4" ], "spl_set_id": [ "06720229-7d58-499e-b7de-cb4bda5ae416" ], "package_ndc": [ "49348-186-20", "49348-186-14" ], "is_original_packager": [ true ], "unii": [ "GR686LBA74", "3980JIH2SW" ] } } ] }