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Colace by Cardinal Health

Dosage form: capsule
Ingredients: docusate sodium 50mg
Labeler: Cardinal Health
NDC Code: 55154-4709

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.

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

Pricipal Display Panel - Pouch

Colace®

(docusate sodium) Capsule

50 mg

Principal Display Panel Bag Label

Colace 

Docusate Sodium Capsules

50 MG Each

10 Capsules

COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeRPC;052
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-4709-460 POUCH in 1 CARTON
1NDC:55154-4709-61 CAPSULE in 1 POUCH
2NDC:55154-4709-010 POUCH in 1 BAG
21 CAPSULE 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/FEIOperations
Cardinal Health188557102REPACK(55154-4709)

Revised: 12/2013
 
Cardinal Health

See also...

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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