Colace by Avrio Health L.P.
Dosage form: capsule
Ingredients: Docusate sodium 50mg
Labeler: Avrio Health L.P.
NDC Code: 67618-100
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.
Colace 100 mg
Active ingredient (in each capsule):
Docusate sodium 100 mg
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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
- 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|
- 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.
D&C Red No. 33, FD&C Red No. 40,
FD&C Yellow No. 6, gelatin, glycerin, PEG
400, propylene glycol, sorbitol, titanium
©2018, Avrio Health L.P.
Dist. by: Avrio Health L.P.
Stamford, CT 06901-3431
docusate sodium capsule
docusate sodium capsule
|Labeler - Avrio Health L.P. (141916531)|
|Registrant - Purdue Pharma LP (932323652)|
|Catalent Pharma Solutions, LLC||051762268||MANUFACTURE(67618-101, 67618-100)|
|PL Developments||800014821||PACK(67618-100, 67618-101)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: laxatives
- FDA Alerts (2)