docusate sodium and sennosides

FDA Drug Profile — Stool Softener Laxative, Stool Softener Plus Stimulant Laxative, Stool Softener Laxative Plus Stimulant, Stool Softener with Stimulant Laxative, Stool Softener

Drug Details

Generic Name
docusate sodium and sennosides
Brand Names
Stool Softener Laxative, Stool Softener Plus Stimulant Laxative, Stool Softener Laxative Plus Stimulant, Stool Softener with Stimulant Laxative, Stool Softener, Stool Softener Plus Stimulant, Stool Softener with laxative, Stool Softener Stimulant laxative, Vegetable Laxative and Stool Softner
Application Number
M007
Sponsor
TOP CARE (Topco Associates LLC)
NDC Codes
35
Dosage Forms
TABLET, TABLET, COATED
Routes
ORAL
Active Ingredients
DOCUSATE SODIUM, SENNOSIDES

Indications and Usage

Uses for overnight relief from occasional constipation (irregularity) generally produces bowel movement in 6 to12 hours

Warnings

Warnings Do not use laxative products for longer than 1 week unless directed by a doctor if you are now taking mineral oil, unless directed by a doctor Ask a doctor before use if you have 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 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.