{"active_ingredient":["Active ingredient (in each softgel) Docusate Sodium 100 mg"],"ask_doctor":["Ask a doctor before use if stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks"],"dosage_and_administration":["Directions take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 1-3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor
"],"effective_time":"20241101","how_supplied":["HOW SUPPLIED: Compare to the active ingredient in Colace® Regular Strength Stool Softener† DOCUSATE SODIUM, 100 mg NDC 68071-3438-3 BOTTLES OF 30 NDC 68071-3438-6 BOTTLES OF 60 STOOL SOFTENER LAXATIVE Gentle, Dependable Stimulant-free SOFTGELS †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com"],"id":"0919f0ef-9139-b605-e063-6294a90af582","inactive_ingredient":["Inactive ingredients citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitol special, white edible ink"],"indications_and_usage":["Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours"],"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 (1-800-2222-1222) right away."],"openfda":{"application_number":["M007"],"brand_name":["DOCUSATE SODIUM"],"generic_name":["DOCUSATE SODIUM"],"manufacturer_name":["NuCare Pharmaceuticals,Inc."],"original_packager_product_ndc":["0904-7280"],"package_ndc":["68071-3438-6","68071-3438-3"],"product_ndc":["68071-3438"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1115005"],"spl_id":["0919f0ef-9139-b605-e063-6294a90af582"],"spl_set_id":["fdf3c8e1-d554-4cdb-e053-6394a90a542e"],"substance_name":["DOCUSATE SODIUM"],"unii":["F05Q2T2JA0"],"upc":["0368071343861"]},"package_label_principal_display_panel":["pdp"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health care professional before use."],"purpose":["Purpose Stool softener laxative"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"fdf3c8e1-d554-4cdb-e053-6394a90a542e","spl_product_data_elements":["DOCUSATE SODIUM DOCUSATE SODIUM FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL GLYCERIN CITRIC ACID MONOHYDRATE SORBITAN DOCUSATE SODIUM DOCUSATE PC1 Oval"],"stop_use":["Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative. These could be a sign of a serious condition. you need to use a stool softener laxative for more than 1 week"],"storage_and_handling":["Other information each softgel contains: sodium 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)"],"version":"2","warnings":["Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative. These could be a sign of a serious condition. you need to use a stool softener laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away."]}