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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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

BISACODYL
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-105
Route of Administration	RECTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bisacodyl (Bisacodyl)	Bisacodyl	10 mg

Inactive Ingredients
Ingredient Name	Strength
Hydrogenated Palm Kernel Oil

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-105-53	12 SUPPOSITORY ( SUPPOSITORY) in 1 CARTON	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/10/1997

Labeler - CARDINAL HEALTH, INC. (097537435)

Registrant - G&W Laboratories, Inc. (001271188)

Establishment
Name	Address	ID/FEI	Operations
G&W Laboratories, Inc.		001271188	MANUFACTURE

Revised: 03/2012 CARDINAL HEALTH, INC.