LAXATIVE- bisacodyl suppository 
Chain Drug Marketing Association, 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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Chain Drug Marketing Association - Bisacodyl Suppository

Active ingredient

Active ingredient (in each Suppository)

Bisacodyl, 10 mg

Purpose

Stimulant Laxative

Keep out of reach of children.

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

Uses

Do not use

Ask a doctor

Stop use and ask a doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Directions

01b UC_Bisacodyl Suppository_12pk_DF box_Directions

Other information

Inactive ingredients

hydrogenated vegetable oil

Warnings

For rectal use only.


May cause abdominal discomfort, faintness, rectal burning, and mild cramps.


01b UC_Bisacodyl Suppository_12pk_PDP

01b UC_Bisacodyl Suppository_12pk_DF box

LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-328
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:63868-328-088 in 1 BOX05/18/2021
11 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 finalpart33412/21/2007
Labeler - Chain Drug Marketing Association, Inc. (011920774)
Registrant - Acino Products, LLC (019385518)
Establishment
NameAddressID/FEIBusiness Operations
Acino Products, LLC019385518manufacture(63868-328)

Revised: 5/2021
Document Id: c2b0a386-1169-8bd5-e053-2995a90a2eec
Set id: aa8e1cb0-cc92-47e8-8a69-f43da94bede3
Version: 3
Effective Time: 20210519
 
Chain Drug Marketing Association, Inc.