Drugplain

Colace 100 mg/1

Docusate sodium · CAPSULE · Atlantis Consumer Healthcare, Inc.

No Recall History
Plain English

Colace is an over-the-counter oral capsule containing 100 mg of docusate sodium used to treat constipation by softening stool. It works by helping water and fats mix into the stool to make bowel movements easier.

Key Facts

Brand Name
Colace
Generic Name
Docusate sodium
NDC Code (Product)
67618-101
Manufacturer
Atlantis Consumer Healthcare, Inc.
Strength
100 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
M007
Marketing Start
01/30/1997

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue4,464 reports
nausea4,398 reports
constipation3,818 reports
pain3,563 reports
dyspnoea3,441 reports
diarrhoea3,320 reports
fall3,164 reports
death2,987 reports
vomiting2,811 reports
asthenia2,713 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves occasional constipation (irregularity) • generally produces a bowel movement within 12 to 72 hours.

Dosage & Administration

Directions adults and children 12 years of age and older take 1 softgel daily or as directed by a doctor. children under 12 years of age ask a doctor

Warnings

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 can be signs of a serious condition you need to use a stool softner laxative for more than 1 week If pregnant or breast-feeding , ask a health care professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

Frequently Asked Questions

What is Colace used for?

Colace is an over-the-counter oral capsule containing 100 mg of docusate sodium used to treat constipation by softening stool. It works by helping water and fats mix into the stool to make bowel movements easier.

Is Colace a controlled substance?

Colace is not classified as a controlled substance by the DEA.

What is the generic name for Colace?

The generic name for Colace is Docusate sodium. There are 12 other brand versions of Docusate sodium.

What is the NDC code for Colace 100 mg/1?

The NDC (National Drug Code) for Colace 100 mg/1 is 67618-101, listed by Atlantis Consumer Healthcare, Inc..

Product NDC

67618-101

Package NDC

67618-101-01

Other Docusate Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)