BISAC-10 BISACODYL STIMULANT LAXATIVE- bisacodyl suppository 
GALEN PHARMACEUTICALS LIMITED

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-10 

Drug Facts

Active ingredient (in each suppository)

Bisacodyl 10 mg

Purpose

Laxative

Uses

• for relief of occasional constipation
• this product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

Do not use
• laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
• laxative products for a period longer than 1 week unless directed by a doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product
it may cause • abdominal discomfort • faintness
                     • rectal burning              • mild cramps
                     • store at temperatures not above 86°F (30°C)

Stop use and ask a doctor if
• rectal bleeding
• failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age: 1 suppository, once daily
• suppository should be moistened with water before inserting.

Other information

• store in well closed containers

Inactive ingredients

polyethylene glycol

Questions? +1-863-434-1782

You may also report serious side effects to this phone number.
Mon - Sun: 24/7

Bisacodyl Stimulant Laxative

Suppositories For Adults

FOR RECTAL USE ONLY

Manufactured by:
Galen Pharmaceuticals Ltd.
334/5 GIDC Estate Waghodia,
Vadodara, Gujarat, India, 391760

Country of Origin: India

Web: www.galenltd.com

Packaging

IMAGE

BISAC-10 BISACODYL STIMULANT LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81440-102
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScore    
ShapeBULLET (Cylindrical) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81440-102-121 in 1 BOX02/15/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/15/2021
Labeler - GALEN PHARMACEUTICALS LIMITED (916655764)
Establishment
NameAddressID/FEIBusiness Operations
GALEN PHARMACEUTICALS LIMITED916655764manufacture(81440-102)

Revised: 4/2023
Document Id: d800c741-5e64-4cec-b32f-a235283527a5
Set id: 10816e1e-b00c-4f6f-a544-278635919d37
Version: 2
Effective Time: 20230428
 
GALEN PHARMACEUTICALS LIMITED