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Colace by Avrio Health L.P.

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 50mg
Labeler: Avrio Health L.P.
NDC Code: 67618-111

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 50 mg

Active ingredients
(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.

©2018, Avrio Health L.P.
Dist. by: Avrio Health L.P.
Stamford, CT 06901-3431

304999-0A

Colace 50mg
28 Clear Soft Gels

COLACE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-111
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
ColorBROWN (clear to light brown) Scoreno score
ShapeOVALSize11mm
FlavorImprint CodeCLR;50
Contains    
Packaging
#Item CodePackage Description
1NDC:67618-111-281 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 finalpart33401/07/1900
Labeler - Avrio Health L.P. (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions051762268MANUFACTURE(67618-111)
Establishment
NameAddressID/FEIOperations
PL Developments800014821PACK(67618-111)

 
Avrio Health L.P.

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Medically reviewed on Oct 11, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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