FDA Label for Unit Dose Bisacodyl

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH TABLET)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
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Unit Dose Bisacodyl Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. 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 Tablet)

Bisacodyl 5 mg

Enteric Coated Tablets

Purpose

Stimulant laxative

Uses

•relieves occasional constipation and irregularity
•this product generally produces bowel movement in 6 to 12 hours

Do Not Use

if you cannot swallow without chewing.

Ask A Doctor Before Use If You Have

•stomach pain, nausea or vomiting
•a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product

•do not chew or crush tablet(s)
•do not use within 1 hour after taking an antacid or milk
•you may have stomach discomfort, faintness or cramps

Stop Use And Ask A Doctor If

•have rectal bleeding or fail to have a bowel movement after use of a laxative. These may 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 and over	take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age	take 1 tablet in a single daily dose
children under 6 years of age	ask a doctor

Other Information

•store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
•avoid excessive humidity

Inactive Ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

(800) 616-2471

Repackaged by Cardinal Health

Zanesville, OH 43701

L5071915-11015

L5071915-21015

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