BISACODYL- bisacodyl suppository 
Acino Products, LLC

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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ACINO - BISACODYL LAXATIVE SUPPOSITORIES

Active Ingredients (per suppository)

Bisacodyl USP, 10  mg

Purpose

Laxative

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

Uses

Warnings

For rectal use only.

Do not use laxative products

Ask a doctor before use if you have

noticed a sudden change in bowel habits that persist over a period of 2 weeks

When using this product

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

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.

Directions

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

01b LBL_Bisacodyl Laxative Suppositories_PDP

01b LBL_Bisacodyl Laxative Suppositories_DF box

BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68784-102
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD (UNII: 8334LX7S21)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68784-102-088 in 1 BOX05/18/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68784-102-1212 in 1 BOX05/18/2021
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:68784-102-1616 in 1 BOX05/18/2021
31 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:68784-102-01100 in 1 BOX05/18/2021
41 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 finalpart33401/01/2005
Labeler - Acino Products, LLC (019385518)
Establishment
NameAddressID/FEIBusiness Operations
Acino Products, LLC019385518manufacture(68784-102)

Revised: 5/2021
Document Id: c29c6c3c-e5cf-2f94-e053-2a95a90a1b41
Set id: eaef702c-3742-4aa2-875a-c7ffd7a98aa0
Version: 3
Effective Time: 20210518
 
Acino Products, LLC