DOCUSATE SODIUM capsule, liquid filled

DOCUSATE SODIUM by

Drug Labeling and Warnings

DOCUSATE SODIUM by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each gelcaps)

Docusate Sodium 100 mg 

Purpose

Stool Softner

Uses

• for the prevention of the dry, hard stools
• for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours

Do not use

if you are currently taking mineral oil, unless directed to so by a doctor.

When abdominal pain, nausea, or vomiting are present for longer than 1 week unless directed by a doctor

Ask a doctor before use if you

notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use abd ask a doctor if you

have rectal bleeding fail to have a bowel movement occur after use.

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 immediately.

Stop use and ask a doctor if you

have rectal bleeding fail to have bowel movement occur after use.

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 immediately.

Directions

• adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime

• children 2 to under 12 years of age: take 1 gelcap at bedtime
• children under 2 years of age: ask a doctor

Other information

• Store at room temperature 15-30°C  (59-86°F) 
• do not use if safety seal under cap is torn or missing

Inactive ingredients

FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

glycerin, polyethylene glycol 400, propylene glycol, purified

water, shellac, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-333-9792

PRICNIPAL DISPLAY PANEL

Compare to the active ingredient in

Colace ® Gel Caps *

STOOL

SOFTENER

DOCUSATE SODIUM 100 mg

Gentle
Effective
Stimulant-Free Relief
100 GELCAPS

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0350
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white, red	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	413
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0350-1	1 in 1 CARTON	03/10/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/10/2020

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(68210-0350)