LAXATIVE- bisacodyl suppository 
GRAXCELL PHARMACEUTICAL, 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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LAXATIVE SUPPOSITORIES, 70795-1010

Active Ingredient (in each suppository)

Bisacodyl, 10  mg

Purpose

Stimulant Laxative

Uses

Warnings

For rectal use only. ​May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Do not use

  • more than once per day
  • for a period longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomitting are present unless directed by a doctor
  • if sealed film around the suppository is torn, damaged, or open.

Ask a doctor

  • before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby

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.

Keep out of reach of children

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

Directions

Table

Other information

store below 30° C (86° F)

Inactive ingredient

hydrogenated vegetable oil

Label 1

Label 2

Label 3

LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1010
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:70795-1010-88 in 1 BOX03/29/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70795-1010-550 in 1 BOX04/22/2017
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:70795-1010-1100 in 1 PACKAGE04/22/2017
31 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 finalpart33403/29/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Revised: 12/2021
Document Id: d3adbcb3-74ef-1ee2-e053-2995a90acbcc
Set id: 5a65d4ab-447f-42bb-b38d-070db523b806
Version: 5
Effective Time: 20211221
 
GRAXCELL PHARMACEUTICAL, LLC