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COLACE(docusate sodium)capsule
2014-11-10 00:10:37 来源: 作者: 【 】 浏览:1046次 评论:0

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

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 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
    VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • #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

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

Made in USA Packaged in Canada

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

LUC4083184-11010

LUC4083184-21010

Colace Carton Label

Pricipal Display Panel - Pouch

Colace®

(docusate sodium) Capsule

50 mg

Colace Pouch

Principal Display Panel Bag Label

Colace®

Docusate Sodium Capsules

50 MG Each

10 Capsules

Bag Label


COLACE
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG 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) docusate sodium 50mg
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 RED Score no score
Shape OVAL Size 11mm
Flavor   Imprint Code RPC;052
Contains  
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-4709-4 60 POUCH ( POUCH) in 1 CARTON contains a POUCH(55154-4709-6)
1 NDC:55154-4709-6 1 CAPSULE ( CAPSULE) in 1 POUCH This package is contained within the CARTON(55154-4709-4)
2 NDC:55154-4709-0 10 POUCH ( POUCH) in 1 BAG contains a POUCH
2   1 CAPSULE ( CAPSULE) in 1 POUCH This package is contained within the BAG(55154-4709-0)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other   06/07/2011  

Labeler -Cardinal Health (188557102)
Registrant -Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Operations
Cardinal Health   188557102 REPACK 
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