COLACE CLEAR- docusate sodium capsule, liquid filled 
Purdue Products LP

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

Colace Clear 50 mg

Active ingredient
(in each soft gel)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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 dose or in divided doses.

adults and children 12 years and overtake 1-6 soft gels daily
children 2 to under 12 years of agetake 1-3 soft gels daily
children under 2 yearsask a doctor

Other information

Inactive ingredients

gelatin,glycerin, PEG 400, propylene glycol, sorbitol

Soft gels are imprinted with edible dye-free ink.

©2014, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
Made in the USA
303458-0A

Colace Clear 50 mg Carton
NDC: 67818-100-28

Colace Clear 50mg
COLACE CLEAR 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBROWN (Clear to light brown) Score2 pieces
ShapeOVALSize11mm
FlavorImprint Code CLR;50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-109-281 in 1 CARTON
128 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/16/2014
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions, LLC051762268MANUFACTURE(67618-109)
Establishment
NameAddressID/FEIBusiness Operations
PL Developments800014821PACK(67618-109)

Revised: 1/2015
Document Id: 50170f82-8611-4f12-b602-b227e8f7b380
Set id: 0fbb189e-62f3-d9bb-cd48-d88e0648eb50
Version: 2
Effective Time: 20150128
 
Purdue Products LP