Active Ingredient (In Each Capsule)
Bisacodyl (USP) 5 mg
Dulcolax Laxative Capsule, Liquid Filled
FDA Label NDC 41167-0222
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 41167-0222). 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 capsule), 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 6 to 12 hours
Warnings
Do not use ■ if you cannot swallow without chewing
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 and cramps
■ do not chew capsule(s)
■ do not use within 1 hour after taking an antacid or milk
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
■ take with a glass of water
| adults and children 12 years of age and over | start with 1 capsule a day. If needed, increase to 2 or 3 capsules a day in a single daily dose. |
| children 6 to under 12 years of age | 1 capsule daily |
| children under 6 years of age | ask a doctor |
Other Information
■ store at 20-25°C (68-77°F)
■ protect from excessive heat and humidity
Inactive Ingredients
anhydrous dextrose, ferric oxide yellow, gelatin, gellan gum, glycerin, hydrogenated cottonseed oil, pectin, sorbitol sorbitan solution, soybean oil
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) 5 mg Stimulant Laxative
LIQUID GEL
LAXATIVE
20 LIQUID GELS
Dulcolaxbisacodyl (usp) 5 mg Stimulant Laxativeliquid Gellaxative20 Liquid Gels (Dulcolax Liquid Gel Laxative 01)
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