Label: LAXATIVE- bisacodyl suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 70795-1010-1, 70795-1010-5, 70795-1010-8 - Packager: GRAXCELL PHARMACEUTICAL, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 21, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each suppository)
- Purpose
- Uses
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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
- Directions
- Other information
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LAXATIVE
bisacodyl suppositoryProduct 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)