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.
Otc - Active Ingredient
Bisacodyl USP 5mg.
Otc - 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.
Otc - Ask Doctor
If you have
Stomach pain, nausea or vomiting
A sudden change in bowel habits that lasts for more than 2 weeks.
Otc - When Using
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.
Otc - 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
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage And Administration
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). Protect from excessive humidity.
Inactive Ingredient
Acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 Aluminum Lake, FD&C yellow #6 Aluminum Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.
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