FDA Label for Bisacodyl
View Indications, Usage & Precautions
Bisacodyl Product Label
The following document was submitted to the FDA by the labeler of this product Sunrise Pharmaceutical 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
Bisacodyl USP 5mg.
Purpose
Stimulant laxative.
Indications And Usage
For temporary 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 Doctor Before Use If You Have
Stomach pain, nausea or vomiting
A sudden change in bowel habits that lasts for more than 2 weeks.
When Using This Product
Do not chew or crush tablet(s).
It may cause stomach discomfort, faintness and cramps.
Do not use within 1 hour after taking an antacid or milk.
Stop Use And Ask A Doctor If
You have rectal bleeding or no bowel movement after using this product. These could be signs of serious condition.
You need to use laxative for more than 1 week
If Pregnant Or Breast Feeding
Ask a health professional before use.
Dosage And Administration
Dosage and Administration text
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 and over | 1 to 3 tablets in a single daily dose |
| Children 6 to under 12 years | 1 tablet in a single daily dose |
| Children under 6 years | Ask a doctor |
Other Information
Store at 20°-25°C(68°-77°F)
Inactive Ingredient
Calcium sulfate, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, edible ink, FD & C yellow #6, gelatin, hydroxypropylymethyl cellulose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline celloluse, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate.
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