LAXATIVE ENTERIC COATED- bisacodyl tablet, coated 
Hy-Vee

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredient (in each enteric coated tablet)

 Bisacodyl, USP 5 mg

Purpose

 Stimulant laxative

Use

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)
  • 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 a serious condition.
  • you need to use a laxative for more than 1 week

If pregnancy 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 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

Other information

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?

Call toll free 1-800-289-8343 Monday-Friday 9AM-4PM CST

Principal Display Panel

Overnight Relief

Laxative Tablets

Stimulant laxative

Gentle yet effective

Bisacodyl, 5 mg

*Compare to DULCOLAX® active ingredient

Enteric Coated Tablets

EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Health Care Products, owner of the registered trademark Dulcolax®

Product Label

Hyvee

Bisacodyl 5 mg tablet

LAXATIVE  ENTERIC COATED
bisacodyl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-086
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
SUCROSE (UNII: C151H8M554)  
POVIDONES (UNII: FZ989GH94E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TCL003
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42507-086-63 1 in 1 CARTON
1 25 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 11/08/2010
Labeler - Hy-Vee (006925671)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013
Document Id: 7e8275a6-111b-4eed-a807-41dd29199343
Set id: 0530439e-a409-49c0-9778-ac9dde7dcc10
Version: 1
Effective Time: 20130206
 
Hy-Vee