DOCUSATE SODIUM 100MG- docusate sodium capsule

Docusate Sodium 100mg by

Drug Labeling and Warnings

Docusate Sodium 100mg by is a Otc medication manufactured, distributed, or labeled by Pharmaceutica North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

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 care professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

KEEP OUT OF REACH OF CHILDREN

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

Other information

each softgel contains: sodium 7 mg
store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

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

Questions or comments? 1-888-788-6472

Product label

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 100MG 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45861-076
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45861-076-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/01/2025

Labeler - Pharmaceutica North America, Inc. (962739699)