Stool Softener Docusate Sodium

DOCUSATE SODIUM ORAL HUMAN OTC DRUG

Stool Softener Docusate Sodium is an FDA drug label for the active ingredient DOCUSATE SODIUM manufactured by Magno-Humphries, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231027.

Generic name
DOCUSATE SODIUM
Manufacturer
Magno-Humphries, Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
54257-902
Application
M007
Label effective
20231027

Active ingredients

Active ingredient (in each softgel) Docusate sodium 100 mg Purpose Stool softener

Indications & Usage

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

Dosage & Administration

Directions Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years of age and older take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Contraindications

Not available.

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 a 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Adverse Reactions

Not available.

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