STRATUSCARE BISACODYL- bisacodyl suppository 
Stratus Pharmaceuticals

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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BISACODYL USP

Drug Facts

Active ingredient (in each suppository)

Bisacodyl 10mg

Purpose

Stimulative laxative

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

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and olderChildren 6 to under 12 yearsChildren under 6
One suppository once daily1/2 suppository once dailyAsk a doctor

Other information

Inactive ingredients

Hydrogenated Vegetable Oil

Questions or comments?

1-800-442-7881

Distributed by:
Stratus Pharmaceuticals Inc
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box

STRATUSCARE

12
Suppositories
Comfort Shaped

Distributed by:
STRATUS
PHARMACEUTICALS INC

NDC 58980-415-12

Gentle Laxative
(BISACODYL USP 10 mg)

WORKS IN
15 MINUTES
TO 1 HOUR

Compare to the active
ingredient in Dulcolax®*

PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box
STRATUSCARE BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-415
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bisacodyl (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) Bisacodyl10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-415-044 in 1 BOX; Type 0: Not a Combination Product05/30/2014
2NDC:58980-415-088 in 1 BOX; Type 0: Not a Combination Product05/30/2014
3NDC:58980-415-1212 in 1 BOX; Type 0: Not a Combination Product05/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/30/2014
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Tarmac Products059890491MANUFACTURE(58980-415)

Revised: 11/2022
Document Id: 5a4c9462-becd-451e-bffa-0e0397cc4d81
Set id: 795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d
Version: 3
Effective Time: 20221102
 
Stratus Pharmaceuticals