Your browser does not support JavaScript! COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]
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RxNorm Names

COLACE (docusate sodium) capsule
[Purdue Products LP]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Drug Facts

Colace 50 mg

Active ingredient (in each capsule):

Docusate sodium 50 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 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 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: 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 yearsask a doctor

Other information

  • each capsule contains: sodium 3 mgVERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

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

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 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 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: 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 yearsask a doctor

Other information

  • each capsule contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

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

©2012, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
302528-0C




Colace 50 mg 30 Capsules Carton

Colace 50 mg 30 Capsules Carton

Colace 100 mg 30 Capsules Carton

Colace Carton
COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67618-100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (docusate) Docusate sodium50 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize1mm
FlavorImprint Code RPC;052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-100-301 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
2NDC:67618-100-601 in 1 CARTON
260 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/30/1997
COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67618-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (docusate) Docusate sodium100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize1mm
FlavorImprint Code RPC;053
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-101-101 in 1 CARTON
110 in 1 BLISTER PACK
2NDC:67618-101-301 in 1 CARTON
230 in 1 BOTTLE, PLASTIC
3NDC:67618-101-601 in 1 CARTON
360 in 1 BOTTLE, PLASTIC
4NDC:67618-101-52250 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/30/1997
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions, LLC051762268MANUFACTURE(67618-101, 67618-100)
Establishment
NameAddressID/FEIBusiness Operations
PL Developments800014821PACK(67618-100, 67618-101)

Revised: 11/2012
 
Purdue Products LP

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