Docusate Sodium 100mg

FDA Drug Profile — Stool Softener, Docusate Sodium

Docusate Sodium 100mg is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including Stool Softener, Docusate Sodium. Available dosage forms: capsule, liquid filled, capsule.

Drug Details

Generic Name
Docusate Sodium 100mg
Brand Names
Stool Softener, Docusate Sodium
Application Number
M007
Sponsor
PuraCap Pharmaceutical LLC
NDC Codes
2
Dosage Forms
CAPSULE, LIQUID FILLED, CAPSULE
Routes
ORAL
Active Ingredients
DOCUSATE SODIUM

Indications and Usage

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

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 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 bowel movement after use of a laxative. These could be signs 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 professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)