Stool Softener by Sam's West, Inc / P & L Development, LLC Drug Facts

Drug Details [pdf]

STOOL SOFTENER- docusate sodium capsule, liquid filled
Sam's West, Inc

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 ingredients (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement within 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 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 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 only by mouth. Doses may be taken as a single daily does or in divided doses.

adults and children 12 years and over	take 1-3 capsules daily
children 2 to under 12 years of age	take 1 capsule daily
children under 2 years	ask a doctor

Other information

each capsule contains: sodium 6 mg
store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special and titanium dioxide.

Questions or comments?

Call toll free 1-888-301-0332 Monday-Friday 8AM-5PM CST

Principal Display Panel

Stool Softener

Compare to Colace® active ingredient*

docusate sodium, 100 mg

relieves constipation

1-3 capsules daily

capsules

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Distributed by:

SAM'S WEST, INC.,

BENTONVILLE, AR 72716

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Labeling

Simply Right Stool Softener TT Capsules

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-110
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
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P10;51A
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 68196-110-04	400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/30/2011	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	10/30/2011	12/31/2019

Labeler - Sam's West, Inc (051957769)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: 9693dd52-937d-48a4-8545-1252cd6e7523

Set id: 04ea9da8-2f2d-4877-9c6b-39014ed3b48d

Version: 2

Effective Time: 20181226