Colace description, usages, side effects, indications, overdosage, supplying and lots more!

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Colace

Purdue Products LP
Purdue Pharma LP




FULL PRESCRIBING INFORMATION

Drug Facts

Colace 50 mg

Active ingredient

Active ingredient (in each capsule):

Docusate sodium 50 mg

Purpose

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 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 mgVERY 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



©2012, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
302525-0C







Drug Facts

Colace 100 mg

Active ingredient

Active ingredient (in each capsule):

Docusate sodium 100 mg

Purpose

Purpose

Stool softener

Uses

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 over
take 1-3
capsules daily
children 2 to under
12 years of age
take 1 capsules
daily
children under 2 years ask a doctor

Other information

  • each capsule 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

©2012, Purdue Products L.P.
Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431
302528-0C




Colace 50 mg 30 Capsules Carton

Colace

Colace 100 mg 30 Capsules Carton

Colace

Colace

Docusate sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) 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 1 mm RPC;052 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 60 in 1 BOTTLE, PLASTIC
3 NDC:67618-100-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 1997-01-30


Colace

Docusate sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67618-101
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 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 1 mm RPC;053 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 30 in 1 BOTTLE, PLASTIC
3 60 in 1 BOTTLE, PLASTIC
4 NDC:67618-101-52 250 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 1997-01-30


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Be sure to consult your doctor before taking any medication!
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