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Stratuscare Bisacodyl

Medically reviewed on May 7, 2018

Dosage form: suppository
Ingredients: Bisacodyl 10mg
Labeler: Stratus Pharmaceuticals
NDC Code: 58980-415

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.

Stratuscare Bisacodyl USP

Drug Facts

Active ingredient (in each suppository)

Bisacodyl 10mg

Purpose

Stimulative laxative

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

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
  • Detach one suppository from the strip and remove from foil
  • Carefully insert well into rectum
  • Do not use more than once per day

Other information
  • Store at 15°C to 30°C (59°F to 86°F). Do not exceed 30°C (86°F).
  • Individually sealed for your protection. Do not use if foil is torn or open.

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 (4) Suppository Box

STRATUSCARE

4
Suppositories
Comfort Shaped

Distributed by:
STRATUS
PHARMACEUTICALS INC

NDC 58980-415-04

Gentle Laxative

(BISACODYL USP 10 mg)

  • Stimulant laxative
  • Gentle yet effective

WORKS IN
15 MINUTES
TO 1 HOUR

Compare to the active
ingredient in Dulcolax®*

STRATUSCARE BISACODYL 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-415
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bisacodyl (Bisacodyl) Bisacodyl10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED SOYBEAN OIL 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58980-415-044 SUPPOSITORY in 1 BOX
2NDC:58980-415-088 SUPPOSITORY in 1 BOX
3NDC:58980-415-1212 SUPPOSITORY in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/30/2014
Labeler - Stratus Pharmaceuticals (789001641)
Establishment
NameAddressID/FEIOperations
Tarmac Products059890491MANUFACTURE(58980-415)

 
Stratus Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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