Label: STRATUSCARE BISACODYL- bisacodyl suppository
- NDC Code(s): 58980-415-04, 58980-415-08, 58980-415-12
- Packager: Stratus Pharmaceuticals
- 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.
Drug Label Information
Updated November 2, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each suppository)
- Purpose
- Uses
-
Warning
for rectal use only
Do not use
- more than once per day
- for a period of longer than one week unless directed by a doctor
- laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
Ask a doctor before use if you have
- noticed a sudden change in bowel habits that persist over a period of two weeks
When using this product you may have abdominal discomfort, faintness, rectal burning and mild cramps
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box
-
INGREDIENTS AND APPEARANCE
STRATUSCARE BISACODYL
bisacodyl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-415 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 HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-415-04 4 in 1 BOX; Type 0: Not a Combination Product 05/30/2014 2 NDC:58980-415-08 8 in 1 BOX; Type 0: Not a Combination Product 05/30/2014 3 NDC:58980-415-12 12 in 1 BOX; Type 0: Not a Combination Product 05/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 05/30/2014 Labeler - Stratus Pharmaceuticals (789001641) Establishment Name Address ID/FEI Business Operations Tarmac Products 059890491 MANUFACTURE(58980-415)
