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Colace by Cardinal Health

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

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.

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


Stool softener

relieves occasional constipation (irregularity)
generally produces a bowel movement in 12 to 72 hours


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
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 years

ask a doctor

Other Information
each capsule contains: sodium 3 mg
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.).

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


(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



Pricipal Display Panel - Pouch


(docusate sodium) Capsule

50 mg

Principal Display Panel Bag Label


Docusate Sodium Capsules

50 MG Each

10 Capsules

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 
polyethylene glycol 400 
propylene glycol 
Product Characteristics
ColorREDScoreno score
FlavorImprint CodeRPC;052
#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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/07/2011
Labeler - Cardinal Health (188557102)
Registrant - Purdue Pharma LP (932323652)
Cardinal Health188557102REPACK(55154-4709)

Revised: 03/2015
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.