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  5. Label Information: Stratuscare Bisacodyl

FDA Label for Stratuscare Bisacodyl

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
    3. PURPOSE
    4. USES
    5. WARNING
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 10 MG (4) SUPPOSITORY BOX

Stratuscare Bisacodyl Product Label

The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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

Otc - When Using



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.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


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®*


* Please review the disclaimer below.