Active Ingredient (In Each Suppository)
Bisacodyl (USP) 10 mg
Dulcolax Laxative Suppository
FDA Label NDC 41167-0210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Dulcolax Laxative (NDC 41167-0210). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each suppository), purpose, use, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Use
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 15 minutes to 1 hour
Warnings
For rectal use only
Ask A Doctor Before Use If You Have
- stomach pain, nausea or vomiting
- noticed a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
it may cause stomach discomfort, faintness, rectal burning and mild cramps
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
- you need to use a 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
adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age ½ suppository in a single daily dose
children under 6 years of age ask a doctor
Other Information
- do not use if individual blister unit is open or torn
- store at 20°-25°C (68°-77°F)
Inactive Ingredient
hard fat
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Keep carton as it contains important product information.
Principal Display Panel
Dulcolax
Bisacodyl (USP) 10 mg Suppository/ Stimulant Laxative
MEDICATED LAXATIVE SUPPOSITORY
4
COMFORT SHAPED
SUPPOSITORIES
DO NOT SWALLOW
Principal Display Paneldulcolaxbisacodyl (usp) 10 mg Suppository/ Stimulant Laxativemedicated Laxative Suppository4comfort Shapedsuppositoriesdo Not Swallow (Dulcolax Medicated Laxative Suppository 01)
* Please review the disclaimer below.
