Stratuscare Bisacodyl Suppository
FDA Label NDC 58980-415

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals for the product Stratuscare Bisacodyl (NDC 58980-415). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each suppository), purpose, uses, warning, do not use, ask a doctor before use if you have, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.