{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 54 } }, "results": [ { "spl_product_data_elements": [ "Colon Detox Docusate sodium and Sennosides DOCUSATE SODIUM DOCUSATE CELLULOSE, MICROCRYSTALLINE MALTODEXTRIN CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID SILICON DIOXIDE D&C YELLOW NO. 10 TITANIUM DIOXIDE SENNOSIDES SENNOSIDES ANHYDROUS DIBASIC CALCIUM PHOSPHATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE FD&C YELLOW NO. 6 P" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active Ingredients Purpose Active ingredients (in each tablet) Purpose Docusate sodium 50 mg Stool softner Sennosides 8.6 mg Laxative" ], "active_ingredient_table": [ "
Active ingredients (in each tablet)Purpose
Docusate sodium 50 mgStool softner
Sennosides 8.6 mgLaxative
" ], "purpose": [ "Purpose Active ingredients (in each tablet) Purpose Docusate sodium 50 mg Stool softner Sennosides 8.6 mg Laxative" ], "purpose_table": [ "
Active ingredients (in each tablet)Purpose
Docusate sodium 50 mgStool softner
Sennosides 8.6 mgLaxative
" ], "indications_and_usage": [ "Uses For relief of occasional constipation (irregularity). This product generally produces bowel movement in 6 to 12 hours." ], "warnings": [ "Warnings Do not use if you are presently taking mineral oil, unless directed by a doctor. laxative products should not be used for a period longer than 1 week unless directed by a doctor. Ask a doctor before use if you have stomach pain nausea vomitting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of a laxative. These may indicate a serious condition. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "do_not_use": [ "Do not use if you are presently taking mineral oil, unless directed by a doctor. laxative products should not be used for a period longer than 1 week unless directed by a doctor." ], "ask_doctor": [ "Ask a doctor before use if you have stomach pain nausea vomitting noticed a sudden change in bowel habits that lasts over 2 weeks" ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of a laxative. These may indicate a serious condition." ], "pregnancy": [ "If pregnant or breast-feeding ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "Directions take preferably at bedtime or as directed by a doctor age starting dose maximum dose adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor" ], "dosage_and_administration_table": [ "
agestarting dosemaximum dose
adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor
" ], "storage_and_handling": [ "Other information each tablet contains: calcium 21 mg each tablet contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F). read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING" ], "inactive_ingredient": [ "Inactive ingredients croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow #10, FD&C Yellow #6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide." ], "questions": [ "Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9AM-5PM EST or https://www.opmx.us" ], "package_label_principal_display_panel": [ "Colon Detox Colon Detox Colon Cleanser Helps Lose Belly Fat Stool Softener 60 Tablets CD" ], "set_id": "0a4d3265-080c-d2ed-e063-6394a90adbee", "id": "11ee012a-51b2-9afd-e063-6294a90a2a5f", "effective_time": "20240221", "version": "2", "openfda": { "application_number": [ "M007" ], "brand_name": [ "Colon Detox" ], "generic_name": [ "DOCUSATE SODIUM AND SENNOSIDES" ], "manufacturer_name": [ "OPMX LLC" ], "product_ndc": [ "69729-151" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DOCUSATE SODIUM", "SENNOSIDES" ], "rxcui": [ "998740" ], "spl_id": [ "11ee012a-51b2-9afd-e063-6294a90a2a5f" ], "spl_set_id": [ "0a4d3265-080c-d2ed-e063-6394a90adbee" ], "package_ndc": [ "69729-151-60" ], "is_original_packager": [ true ], "upc": [ "0810053181355" ], "unii": [ "F05Q2T2JA0", "3FYP5M0IJX" ] } } ] }