COLACE- docusate sodium capsule 
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.

----------

Drug Facts

Colace 50 mg

Active ingredient (in each capsule):

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 over take 1-6 capsules daily
children 2 to under 12 years of age take 1-3 capsules daily
children under 2 years ask a doctor

Other information

Keep tightly closed.

Inactive ingredients

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



©2012, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
302525-0C







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 capsules daily
children under 2 years ask 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

©2016, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
304285-0




Colace 50 mg 30 Capsules Carton

302525-0C

Colace 100 mg 30 Capsules Carton

304285-0A
COLACE 
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-100
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Docusate sodium (UNII: F05Q2T2JA0) (docusate - UNII:M7P27195AG) Docusate sodium 50 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED Score no score
Shape OVAL Size 1mm
Flavor Imprint Code RPC;052
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-100-30 1 in 1 CARTON 01/30/1997
1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2 NDC:67618-100-60 1 in 1 CARTON 01/30/1997
2 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/30/1997
COLACE 
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-101
Route of Administration ORAL
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED Score no score
Shape OVAL Size 1mm
Flavor Imprint Code RPC;053
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-101-10 1 in 1 CARTON 01/30/1997
1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:67618-101-30 1 in 1 CARTON 01/30/1997
2 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3 NDC:67618-101-60 1 in 1 CARTON 01/30/1997
3 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4 NDC:67618-101-52 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/30/1997
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/30/1997
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions, LLC 051762268 MANUFACTURE(67618-101, 67618-100)
Establishment
Name Address ID/FEI Business Operations
PL Developments 800014821 PACK(67618-100, 67618-101)

Revised: 2/2017
Document Id: cc5911b2-d9f7-6d43-acd2-31812a9ac392
Set id: 7793fced-e8ee-44e2-b212-dd2a59a5f462
Version: 3
Effective Time: 20170223
 
Purdue Products LP