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Bisacody

TOP CARE (Topco Associates LLC)

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

 Bisacodyl USP 5 mg

Purpose

 Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a 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
  • 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
  • it may cause stomach discomfort, faintness and cramps

Stop use and ask a doctor if

  • you have rectal bleeding or no 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 pregnancy or breast-feeding,

 ask a health professions 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 yers of age 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

Bisacody Other information

  •  store between 20º-25ºC (68º-77ºF)

Inactive ingredients

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 (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

Questions or comments?

Cal toll free 1-888-423-0139

Principal Display Panel

OVERNIGHT RELIEF

Laxative Tablets

Bisacodyl, USP 5 mg

  • Gentle, predictable, overnight relief from constipation

COMPARE TO DULCOLAX® active ingredient*

Enteric Coated Tablets

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc.,distributor of Dulcolax® Laxative.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60077

QUESTIONS? 1-888-423-0139

topcare@topco.com

Product Label

Bisacody
Top Care Laxative Tablet

Bisacody

Bisacodyl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-190
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
CALCIUM SULFATE ANHYDROUS
ANHYDROUS LACTOSE
carnauba wax
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
MAGNESIUM STEARATE
cellulose, microcrystalline
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
talc
titanium dioxide
POLYVINYL ACETATE PHTHALATE
SUCROSE
POVIDONES
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
ORANGE 6 mm TCL003 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BLISTER PACK
2 NDC:36800-190-25 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-01-10


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Be sure to consult your doctor before taking any medication!
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