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Colace

Cardinal Health
Purdue Pharma LP

Colace 50 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Stool Softener

Gentle, Effective, Stimulant-Free for Comfortable Relief

Active Ingredient (in each capsule)

Docusate sodium 50 mg

Purpose

Stool softener

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours
  • if you are presently taking mineral oil, unless told to do so by a doctor
  • 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 years ask a doctor
  • 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

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

Colace

Pricipal Display Panel - Pouch

Colace®

(docusate sodium) Capsule

50 mg

Colace

Principal Display Panel Bag Label

Colace 

Docusate Sodium Capsules

50 MG Each

10 Capsules

Colace

Colace

docusate sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-4709(NDC:67618-100)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 50 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
polyethylene glycol 400
propylene glycol
sorbitol

Product Characteristics

Color Size Imprint Code Shape
RED 11 mm RPC;052 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-4709-6 1 in 1 POUCH
2 1 in 1 POUCH
3 NDC:55154-4709-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-07


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Be sure to consult your doctor before taking any medication!
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