STOOL SOFTENER- docusate sodium capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• for temporary relief of occasional constipation and irregularity
• this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have:

• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if:

• you have rectal bleeding or no bowel movement after using this product. This could be signs of a serious condition.
• you need to use 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 with glass of water

adults and children 12 years and over:

• 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

  Children under 12 years of age:

• 1 liquid gel daily

Children under 2 years of age

Ask a doctor

Other Information

• store at 15-30 °C (59-86 °F)
• protect from excessive humidity
• do not use this product if the safety seal under the cap is torn or missing

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions or Comments

Call 1-855-314-1850

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 076168-069-05 – 25 COUNT

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-069
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	5mm
Flavor		Imprint Code	V100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-069-05	25 in 1 BOTTLE
1		1 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/01/2013

Labeler - Velocity Pharma (962198409)