Bisacodyl Usp

Bisacodyl Usp
SPL v5
SPL
SPL Set ID 795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d
Route
RECTAL
Published
Effective Date 2025-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (10 mg)
Inactive Ingredients
Hydrogenated Soybean Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-30
Description

Drug Facts

Purpose

Stimulative laxative

Medication Information

Purpose

Stimulative laxative

Description

Drug Facts

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

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

Section 53414-9

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

Warning

for rectal use only

Directions
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
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
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

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.
Ask A Doctor Before Use If You Have
  • noticed a sudden change in bowel habits that persist over a period of two weeks
Active Ingredient (in Each Suppository)

Bisacodyl 10mg

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)

  • Stimulant laxative
  • Gentle yet effective

WORKS IN

15 MINUTES

TO 1 HOUR

Compare to the active

ingredient in Dulcolax®*

Structured Label Content

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 53414-9 (53414-9)

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

Purpose

Stimulative laxative

Warning

for rectal use only

Directions
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
Do Not Use (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
Other Information (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 (Inactive ingredients)

Hydrogenated Vegetable Oil

Questions Or Comments? (Questions or comments?)

1-800-442-7881

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • noticed a sudden change in bowel habits that persist over a period of two weeks
Active Ingredient (in Each Suppository) (Active ingredient (in each suppository))

Bisacodyl 10mg

Principal Display Panel 10 Mg Blister Pack Box (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)

  • Stimulant laxative
  • Gentle yet effective

WORKS IN

15 MINUTES

TO 1 HOUR

Compare to the active

ingredient in Dulcolax®*

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.695197 · Updated: 2026-03-14T23:08:22.901159