DOCUSATE SODIUM 100MG capsule, liquid filled

DOCUSATE SODIUM 100MG by

Drug Labeling and Warnings

DOCUSATE SODIUM 100MG by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Aenova Romania SRL, Green Star Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

. Relieves occasional constipation (irregularity)
. Generally produces bowel movement in 12 to 72 hours

Warnings

Warnings

Do not use if

if you are presently taking mineral oil, unless directed to 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.

Keep out of reach of children.

In case of overdose,

get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and older - Take 1-3 softgels once daily or in divided doses

Children under 12 years old - Take 1 softgel once daily
Children under 2 years - Ask a doctor

Other information

. Each softgel contains: sodium 5mg
. Store at room temperature 15-30°C (59-86°F)and avoid excessive heat

Inactive ingredients

Citric acid, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink.

Questions or comments?

(855)-280-1079

SPL UNCLASSIFIED SECTION

*This product is not affiliated with the owner of the trademark Colace®

Distributed in USA by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX,
78701, USA
customerservice@drsimi.com
www.drsimi.com

PRINCIPAL DISPLAY PANEL

Dr. Simi

Compare to the active ingredient in Colace®*

NDC: 85786-502-24
Docusate Sodium 100 mg

Stool Softener

Laxative

24 softgels

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 100MG 
docusate sodium 100mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-502
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
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-502-24	24 in 1 CARTON; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	01/01/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Aenova Romania SRL		565466997	manufacture(85786-502)

Establishment
Name	Address	ID/FEI	Business Operations
Green Star Labs, Inc.		118673251	pack(85786-502)