FDA Label for Dulcolax Laxative

View Indications, Usage & Precautions

Dulcolax Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Capsule)



Bisacodyl (USP) 5 mg


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 overstart 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 age1 capsule daily
children under 6 years of ageask 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


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