BISAC-EVAC - bisacodyl suppository 
Cosette Pharmaceuticals, 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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BISAC-EVAC™
Bisacodyl USP 10 mg 

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

Unit Carton
BISAC-EVAC  
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0109
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0713-0109-1212 in 1 CARTON; Type 0: Not a Combination Product05/22/199103/31/2021
2NDC:0713-0109-01100 in 1 CARTON; Type 0: Not a Combination Product05/22/199104/30/2021
3NDC:0713-0109-088 in 1 CARTON; Type 0: Not a Combination Product05/22/199104/30/2021
4NDC:0713-0109-5050 in 1 CARTON; Type 0: Not a Combination Product05/22/199104/30/2021
5NDC:0713-0109-05500 in 1 CARTON; Type 0: Not a Combination Product05/22/199104/30/2021
6NDC:0713-0109-101000 in 1 CARTON; Type 0: Not a Combination Product05/22/199109/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/22/199104/30/2021
Labeler - Cosette Pharmaceuticals, Inc. (116918230)
Registrant - Cosette Pharmaceuticals, Inc. (116918230)
Establishment
NameAddressID/FEIBusiness Operations
Cosette Pharmaceuticals, Inc.116918230analysis(0713-0109) , manufacture(0713-0109) , label(0713-0109) , pack(0713-0109)

Revised: 6/2021
 
Cosette Pharmaceuticals, Inc.