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COLACE(docusate sodium) capsule
2014-11-10 00:11:36 来源: 作者: 【 】 浏览:1009次 评论:0

Drug Facts
Colace 50 mg
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 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 1-6
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 tablet 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

D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol

 

©2009 Purdue Products L.P.

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

301635-0E

 

Colace

50mg

Colace Docusate Sodium 50mg

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 years ask 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

 

Colace

100mg

Colace Docusate Sodium 100mg

COLACE
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 1mm
Flavor   Imprint Code RPC;052
Contains  
Packaging
# NDC Package Description Multilevel Packaging
1 67618-100-10 2BLISTER PACKIn1CARTON contains a BLISTER PACK
1   5CAPSULEIn1BLISTER PACK This package is contained within the CARTON(67618-100-10)
2 67618-100-30 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
2   30CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-100-30)
3 67618-100-60 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
3   60CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-100-60)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/30/1957  

COLACE
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 67618-101
Route of Administration ORAL DEA Schedule  
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
docusate sodium(docusate) docusate sodium 100mg
Inactive Ingredients
Ingredient Name Strength
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
Color RED (Two-toned- opaque light beige and clear red) Score no score
Shape OVAL Size 1mm
Flavor   Imprint Code RPC;053
Contains  
Packaging
# NDC Package Description Multilevel Packaging
1 67618-101-02 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
1   2CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-101-02)
2 67618-101-03 2CAPSULEIn1BLISTER PACK None
3 67618-101-30 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
3   30CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-101-30)
4 67618-101-35 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
4   35CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-101-35)
5 67618-101-60 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
5   60CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-101-60)
6 67618-101-26 2BOTTLEIn1BOX contains a BOTTLE, PLASTIC
6   60CAPSULEIn1BOTTLE, PLASTIC This package is contained within the BOX(67618-101-26)
7 67618-101-52 1BOTTLEIn1CARTON contains a BOTTLE, PLASTIC
7   250CAPSULEIn1BOTTLE, PLASTIC This package is contained within the CARTON(67618-101-52)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/30/1957  

Labeler -Purdue Products LP(141916531)
Registrant -Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Operations
Anderson Packaging, Inc   053210722 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Wellspring   251086799 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC   051762268 MANUFACTURE 
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