STOOL SOFTENER- docusate sodium capsule, liquid filled 
Costco Wholesale

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 softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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 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

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

Other information

Inactive ingredients

D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE COLACE® ACTIVE INGREDIENT †

KIRKLAND SIGNATURE

Stool Softener

Docusate Sodium, 100 mg

Gentle, Effective relief

Stimulant-Free for comfortable relief

Relieves Constipation

SOFTGELS

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

Distributed by: PL Developments

Westbury, NY 11590 U.S.A 1-877-753-3935

For: Costco Wholesale Corporation

P.O. Box 34535, Seattle, WA 98124-1535

USA 1-800-774-2678 www.costco.com

Product of USA

GLUTEN FREE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Product Labeling

Kirkland Signature Costco

Docusate sodium 100 mg softgels

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-110
Route of Administration ORAL DEA Schedule     
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
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)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color RED, WHITE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code P10;S78;SCU2
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63981-110-40 400 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 07/30/2013
Labeler - Costco Wholesale (103391843)

Revised: 9/2013
Document Id: 4fd05ca4-8dc0-4d01-831e-ac7386f829fb
Set id: 7adb1c79-3e06-4ac1-b286-5d422e8501f9
Version: 1
Effective Time: 20130918
 
Costco Wholesale