STOOL SOFTENER- docusate sodium capsule

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Docusate sodium 100mg

Purpose

Stool softener

Use(s)

• 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 a period of 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
  
  

Pregnancy/Breastfeeding

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) right away.

Directions

• Take only by mouth.

Adults and children 12 years and over: take 1-3 softgels, daily. Doses may be taken as a single daily dose or in divided doses.

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 5mg
• VERY LOW SODIUM
  
• do not use if imprinted safety seal under cap is broken or missing.
  
  

Storage

• store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Inactive ingredients

black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C
yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water,
sorbitol special

Questions

Call 1-888-952-0050 Monday through
Friday 9am-5pm

Principal Display Panel

Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-420
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red, white	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	PC18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-420-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2015
2	NDC: 69168-420-81	400 in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2021
3	NDC: 69168-420-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/10/2015

Labeler - Allegiant Health (079501930)