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Colace Clear by Purdue Products LP

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 50mg
Labeler: Purdue Products LP
NDC Code: 67618-109

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.

Drug Facts

Colace Clear 50 mg

Active ingredient
(in each soft gel)

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 overtake 1-6 soft gels daily
children 2 to under 12 years of agetake 1-3 soft gels daily
children under 2 yearsask a doctor

Other information

  • each soft gel 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.

Inactive ingredients

gelatin,glycerin, PEG 400, propylene glycol, sorbitol

Soft gels are imprinted with edible dye-free ink.

©2014, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
Made in the USA
303458-0A

Colace Clear 50 mg Carton
NDC: 67818-100-28

COLACE CLEAR 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorBROWN (Clear to light brown) Score2 pieces
ShapeOVALSize11mm
FlavorImprint CodeCLR;50
Contains    
Packaging
#Item CodePackage Description
1NDC:67618-109-281 BOTTLE in 1 CARTON
128 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/16/2014
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions, LLC051762268MANUFACTURE(67618-109)
Establishment
NameAddressID/FEIOperations
PL Developments800014821PACK(67618-109)

Revised: 01/2015
 
Purdue Products LP

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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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