STOOL SOFTENER- docusate sodium capsule

STOOL SOFTENER by

Drug Labeling and Warnings

STOOL SOFTENER by is a Otc medication manufactured, distributed, or labeled by Valu Merchandisers Company (Best Choice), P and L Development of New York Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

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

Warnings - Do not use

• if you are currently taking mineral oil, unless directed 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 and ask a doctor if

• you have rectal bleeding
• you fail to have a bowel movement after use

If pregnant or breastfeeding

ask a health care 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

• adults and children 12 years of age and over: take 1- 3 capsules, preferably at bedtime
  
• children 6 to 12 years of age: take 1 capsule at bedtime

Other information

• each capsule contains: sodium 6 mg
• store at controlled room temperature 15o - 30o C (59o- 86o F)
• do not use if imprinted safety seal under cap is broken or missing.
• *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

D&C Red #33, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water.

Questions or Comments?

Call toll free: 1-877-753-3935

Principal Display Panel

Compare to active ingredient in COLACE®*

stool softener

Docusate sodium 100 mg

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Product Label

Docusate Sodium 100 mg

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63941-146
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)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	P10;51A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63941-146-01	1 in 1 BOX
1		100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	08/24/2010

Labeler - Valu Merchandisers Company (Best Choice) (868703513)

Registrant - P and L Development of New York Corporation (800014821)