STOOL SOFTENER by Care One (American Sales Company) / P & L Development, LLC Drug Facts

Drug Details [pdf]

STOOL SOFTENER- docusate sodium capsule, liquid filled
Care One (American Sales Company)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 one 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 breast-feeding,

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 and over: take 1- 2 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, edible ink, 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.

Principal Display Panel

Compare to active ingredient of COLACE®*

stool softener

Docusate sodium 100 mg

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

Product Label

Docusate Sodium 100 mg

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-115
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
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)
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 41520-115-25	1 in 1 BOX	07/20/2010	12/01/2019
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41520-115-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2010	12/01/2019
3	NDC: 41520-115-20	250 in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2010	12/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	07/20/2010	12/01/2019

Labeler - Care One (American Sales Company) (809183973)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2012

Document Id: e12462d6-7d6c-4d7a-b057-11129e97f9a5

Set id: 1c5aa329-441c-40de-bda6-8132caf25ae9

Version: 2

Effective Time: 20121227