Label: LAXATIVE- bisacodyl suppository
- NDC Code(s): 70795-1010-1, 70795-1010-5, 70795-1010-8
- Packager: GRAXCELL PHARMACEUTICAL, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 21, 2021
If you are a consumer or patient please visit this version.
- Active Ingredient (in each suppository)
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.
- Other information
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70795-1010 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 10 mg Inactive Ingredients Ingredient Name Strength FAT, HARD (UNII: 8334LX7S21) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70795-1010-8 8 in 1 BOX 03/29/2017 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70795-1010-5 50 in 1 BOX 04/22/2017 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:70795-1010-1 100 in 1 PACKAGE 04/22/2017 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/29/2017 Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)