BISACODYL USP

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 10mg

Purpose

OTC - PURPOSE SECTION

Stimulative laxative

Uses

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

for rectal use only

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• noticed a sudden change in bowel habits that persist over a period of two weeks

OTC - WHEN USING SECTION

When using this product you may have abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older	Children 6 to under 12 years	Children under 6
One suppository once daily	1/2 suppository once daily	Ask 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

Hydrogenated Vegetable Oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-442-7881

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 10 mg Blister Pack Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRATUSCARE

12
Suppositories
Comfort Shaped

Distributed by:
STRATUS
PHARMACEUTICALS INC

NDC 58980-415-12

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^®*

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

• Stratuscare Bisacodyl
• Bisacodyl
• DEACETYLBISACODYL
• HYDROGENATED SOYBEAN OIL

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.