COLACE
-
docusate sodium capsule
Purdue Products LP
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Colace 50 mg
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
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 capsule |
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| 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 |
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| 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 | |