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Bisacodyl

Cardinal Health

Bisacodyl Enteric Coated Tablet


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Drug Facts

Active Ingredient (in each tablet)

Bisacodyl 5mg

Purpose

 Stimulant laxative

Use(s)

 -relieves occasional constipation and irregularity

 -this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

 Do not use if you cannot swallow without chewing

Ask a doctor before use if

 -you have a sudden change in bowel habits that lasts over 2 weeks

-stomach pain, nausea or vomiting

When using this product

 -do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet

-you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

 -you have rectal bleeding or fail to have a bowel movement after use. These may be signs of a serious condition.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

 If pregnant or breast-feeding ask a doctor before use.

Keep out of reach of children

This package is intended for institutional use only., Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over- take 1 to 3 tablets (usually 2) in a single daily dose

children 6 to under 12 years - take 1 tablet daily

children under 6 years - ask a doctor

Bisacodyl Other information

Storage -Store at 20-25 C (68-77 F) excursions permitted between 15-30 C (59-86 F)

[See USP Controlled Rrom Temperature].

-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 simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearinc acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate.

Generic Section

Distributed by

MAJOR PHARMACEUTIALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By LNK, Hauppauge, NY 11788

Questions

 Questions or Comments? (800) 616-2471

MAJOR is a trademark owned by its respective owner.

Repackaged by Cardinal Health

Zanesville, OH 43701

L3511797-10314

Principal Display Panel

 Bisacodyl Enteric Coated Tabs, USP 5mg

Enteric Coated Tablets

Delayed Release

10 Tablets

Bisacodyl

Bisacodyl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-0674(NDC:0904-7927)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bisacodyl Bisacodyl 5 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
APIS MELLIFERA
CALCIUM SULFATE
carnauba wax
cellulose, microcrystalline
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
LACTOSE
MAGNESIUM STEARATE
SHELLAC
POLYVINYL ACETATE PHTHALATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCROSE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
ORANGE 5 mm 5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-0674-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-02


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Be sure to consult your doctor before taking any medication!
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