COLACE- docusate sodium capsule
Purdue Products LP
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Ask a doctor before use if you have
Stop use and ask a doctor if
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 |
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
Ask a doctor before use if you have
Stop use and ask a doctor if
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 |
| COLACE
docusate sodium capsule |
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| COLACE
docusate sodium capsule |
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| Labeler - Purdue Products LP (141916531) |
| Registrant - Purdue Pharma LP (932323652) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Catalent Pharma Solutions, LLC | 051762268 | MANUFACTURE(67618-101, 67618-100) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| PL Developments | 800014821 | PACK(67618-100, 67618-101) | |