BISACODYL - bisacodyl suppository 
CARDINAL HEALTH, INC.

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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Bisacodyl Suppositories

ACTIVE INGREDIENT (in each suppository)

Bisacodyl USP, 10 mg

PURPOSE

Laxative

USES

For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.

WARNINGS

For rectal use only

Do not use
laxative products for a period longer than one week unless directed by a doctor

Ask a doctor before use if you have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits that lasts longer than 2 weeks

Stop use and ask a doctor
if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.

IF PREGNANT OR BREAST FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• Remove foil. Insert suppository well into rectum touching the bowel wall. Retain about 15 to 20 minutes.
     Direction Chart
• In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly.

OTHER INFORMATION

Store at room temperature

INACTIVE INGREDIENT

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-102-53
LEADER®
BISACODYL SUPPOSITORIES
LAXATIVE
FOR PROMPT RELIEF OF CONSTIPATION
12 BISACODYL SUPPOSITORIES 10 MG EACH
Compare to Dulcolax® active ingredient*
Satisfaction Guaranteed

Unit Carton
BISACODYL  
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-102
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bisacodyl (UNII: 10X0709Y6I) (Bisacodyl - UNII:10X0709Y6I) Bisacodyl10 mg
Inactive Ingredients
Ingredient NameStrength
Hydrogenated Palm Kernel Oil (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-102-5312 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/10/1997
Labeler - CARDINAL HEALTH, INC. (097537435)
Registrant - G&W Laboratories, Inc. (001271188)
Establishment
NameAddressID/FEIBusiness Operations
G&W Laboratories, Inc.001271188MANUFACTURE

Revised: 3/2012
Document Id: 4e9287f3-87a6-967b-8f68-b81821a4b2fe
Set id: af84c8aa-02fa-758f-0072-2eedf60e68ae
Version: 2
Effective Time: 20120308
 
CARDINAL HEALTH, INC.