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Colace by Physicians Total Care, Inc.

Dosage form: capsule
Ingredients: docusate sodium 100mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-2337

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 100 mg
Active ingredient (in each capsule)

Docusate sodium 100 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 movements that continues over a period of 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
capsule daily
children under 2 yearsask a doctor

Other Information
  • each tablet 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

©2009 Purdue Products L.P.

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

302112-0B

Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

Colace

100mg

NDC 54868-2337-2

30 capsules


COLACE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2337(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 
FD&C YELLOW NO. 6 
gelatin 
glycerin 
polyethylene glycol 400 
propylene glycol 
sorbitol 
titanium dioxide 
Product Characteristics
ColorRED (Two-toned- opaque light beige and clear red) Scoreno score
ShapeOVALSize1mm
FlavorImprint CodeRPC;053
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-2337-21 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
130 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/08/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 03/2010
 
Physicians Total Care, Inc.

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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