STOOL SOFTENER capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Good Sense. 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

• stomach pain
• nausea
• vomiting
• notice a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
• you need a laxative for more than 1 week

If pregnant or 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 to 3 softgels daily. This dose 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 of age: 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
• Store at room temperature 15°-30°C (59°-86°F), protect from excessive humidity.

Inactive ingredients

Anhydrous citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,

propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

Questions/Comments

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

Principal Display Panel

Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
stool softener capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-424
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	PC1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-424-24	1 in 1 CARTON	06/18/2024	08/04/2025
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50804-424-25	1 in 1 CARTON	06/18/2024
2		25 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 Drug	M007	06/18/2024

Labeler - Good Sense (076059836)