DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium USP 100 mg

Purpose

Stool softener

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

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 capsules daily
• children 2 to under 12 years of age: take 1 capsule daily
• children under 2 years: ask a doctor

Other information

• each softgel contains: Sodium 5 mg
• store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F).

Keep tightly closed.

Inactive ingredient

FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan solution, water.

TAMPER EVIDENT

Do not use if safety seal under cap is broken or missing

Manufactured by

Softgel Healthcare Pvt. Ltd.,

Survey No. 20/1,

Vandalur-Kelambakkam Road,

Pudupakkam Village,

Kancheepuram District,

Tamilnadu - 603 103, India.

Mfg. Lic. No.: XXXXXXXXXXXX

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-0440
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
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-0440-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	08/31/2024

Labeler - Softgel Healthcare Pvt Ltd (675584180)