COLACE- docusate sodium capsule 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Colace 50 mg

Drug Facts
Colace® (docusate sodium) Capsules 50 mg

Stool Softener

Gentle, Effective, Stimulant-Free for Comfortable Relief

Active Ingredient (in each capsule)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

This package is intended for institutional use only.

This package is not child resistant.

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 mg
    VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed.
  • #1 Doctor Recommended Stool-Softener Brand
  • see window for lot number and expiration date
  • Questions? 1-888-726-7535 (8am-5pm, EST, Mon.-Fri.).
  • www.colacecapsules.com

Inactive ingredients

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

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

Repackaged by: Cardinal Health Zanesville, OH 43701

Principal Display Panel - Carton

NDC: 55154-4709-4

Colace®

(docusate sodium) Capsules

50 mg

60 Capsules

Stool Softener

Gentle, Effective, Stimulant-Free for Comfortable Relief

Dist. by: Purdue Products L.P.

Stamford, CT 06901-3431

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC4083184-10312

LUC4083184-20312

bag label

Pricipal Display Panel - Pouch

Colace®

(docusate sodium) Capsule

50 mg

Pouch

Principal Display Panel Bag Label

Colace 

Docusate Sodium Capsules

50 MG Each

10 Capsules

bag label
COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-4709(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
ShapeOVALSize11mm
FlavorImprint Code RPC;052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-4709-460 in 1 CARTON
1NDC:55154-4709-61 in 1 POUCH
2NDC:55154-4709-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/07/2011
Labeler - Cardinal Health (188557102)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-4709)

Revised: 12/2013
Document Id: be3c2f88-2019-4c35-9b34-97a3dfc337aa
Set id: 99bf708a-d746-4229-8b7d-0739a339cc21
Version: 4
Effective Time: 20131203
 
Cardinal Health