STOOL SOFTENER- docusate sodium capsule

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by BJWC (Berkley & Jensen / BJ's), TIME CAP LABORATORIES, INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)

Docusate sodium USP 100 mg

PURPOSE

Purpose

Stool softener

INDICATIONS & USAGE

Uses:

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

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

DOSAGE & ADMINISTRATION

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

• 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 SAFETY INFORMATION

Other information

• each capsule contains: sodium 6 mg
• keep tightly closed.
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

INACTIVE INGREDIENT

Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

730T Docusate Sodium 100mg 400ct

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-730
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
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	red (Pinkish red light beige translucent)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	102
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-730-40	400 in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	08/20/2025

Labeler - BJWC (Berkley & Jensen / BJ's) (159082692)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(68391-730)