BISAC-EVAC- bisacodyl suppository

BISAC-EVAC by

Drug Labeling and Warnings

BISAC-EVAC by is a Otc medication manufactured, distributed, or labeled by Cosette Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. These may be signs of a serious condition.

IF PREGNANT OR BREAST FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

see chart below for dose
remove foil wrapper
insert suppository well up into the rectum as indicated, and retain it about 15 to 20 minutes

• adults and children 12 years and over:

  1 suppository once daily.

• children 6 years to under 12 years:

  1/2 suppository once daily

• children under 6 years:

  ask a doctor

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: 0713-0109-08
G&W®
BISAC-EVAC™
Bisacodyl USP LAXATIVE
8 SUPPOSITORIES 10 mg each

INGREDIENTS AND APPEARANCE

BISAC-EVAC  
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0713-0109
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0713-0109-12	12 in 1 CARTON; Type 0: Not a Combination Product	05/22/1991
2	NDC: 0713-0109-01	100 in 1 CARTON; Type 0: Not a Combination Product	05/22/1991
3	NDC: 0713-0109-08	8 in 1 CARTON; Type 0: Not a Combination Product	05/22/1991
4	NDC: 0713-0109-50	50 in 1 CARTON; Type 0: Not a Combination Product	05/22/1991
5	NDC: 0713-0109-05	500 in 1 CARTON; Type 0: Not a Combination Product	05/22/1991
6	NDC: 0713-0109-10	1000 in 1 CARTON; Type 0: Not a Combination Product	05/22/1991

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/22/1991

Labeler - Cosette Pharmaceuticals, Inc. (116918230)

Registrant - Cosette Pharmaceuticals, Inc. (116918230)

Establishment
Name	Address	ID/FEI	Business Operations
Cosette Pharmaceuticals, Inc.		116918230	analysis(0713-0109) , manufacture(0713-0109) , label(0713-0109) , pack(0713-0109)