COLACE - docusate sodium capsule 
Physicians Total Care, 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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Colace 50 mg

Drug Facts
Colace 100 mg
Active ingredient (in each capsule)

Docusate sodium 100 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 over
take 1-3
capsules daily
children 2 to under
12 years of age
take 1
capsule daily
children under 2 yearsask a doctor

Other Information

Keep tightly closed.

Inactive ingredients

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide

©2009 Purdue Products L.P.

Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431

302112-0B

Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

Colace

100mg

NDC 54868-2337-2

30 capsules

Colace Docusate Sodium 100mg

COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2337(NDC:67618-101)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG) docusate sodium100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
gelatin (UNII: 2G86QN327L)  
glycerin (UNII: PDC6A3C0OX)  
polyethylene glycol 400 (UNII: B697894SGQ)  
propylene glycol (UNII: 6DC9Q167V3)  
sorbitol (UNII: 506T60A25R)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (Two-toned- opaque light beige and clear red) Scoreno score
ShapeOVALSize1mm
FlavorImprint Code RPC;053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-2337-21 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/08/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 3/2010
Document Id: a407b7b0-d214-4f75-9c48-669e3421d5c9
Set id: a6ffb144-0679-4702-8d97-7a78e176911e
Version: 1
Effective Time: 20100329
 
Physicians Total Care, Inc.