bisacodyl suppositories 443

bisacodyl suppositories 443
SPL v6
SPL
SPL Set ID a747a57a-028e-70ea-e053-2a95a90ac184
Route
rectal
Published
Effective Date 2018-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (10 mg)
Inactive Ingredients
fat, hard

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: white
Marketing Status
otc monograph drug active Since 2019-11-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For rectal use only

Active Ingredient

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Indications and Usage

Uses

  • relieves occasional constipation
  • this product generally produces a bowel movement in 15 minutes to 1 hour
Dosage and Administration

Directions

  • tear off one suppository from the strip
  • peel apart the wrapper
  • continue peeling apart to almost the full length of the suppository (see illustration at the right)
  • gently remove the suppository from the wrapper
  • lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out
  • retain it for about 15 to 20 minutes.
  • Do not exceed recommended dose
  • if suppository seems soft, place in refrigerator for a short time before use

adults and children 12 years and over

1 suppository once daily
children under 12 years Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at temperatures below 25 C (77F)
  • Made in India
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • you have rectal bleeding or you fail to have bowel movement after using a laxative. These may be signs of a serious condition.
  • you need to use a laxative product for more than one week
Section 50567-7

When using this product you may experience

  • rectal burning
  • mild cramps
  • abdominal discomfort
  • faintness
Section 50569-3

Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period 2 weeks.

Section 50570-1

Do not use

when abdominal pain, nausea, or vomiting are present.

Section 51727-6

Inactive ingredient hard fat

Section 51945-4

Section 53413-1

Questions or Comments? 1-800-540-3765

Section 53414-9

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

Section 55105-1

Purpose

Stimulant Laxative

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Active Ingredient (55106-9)

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Indications and Usage (34067-9)

Uses

  • relieves occasional constipation
  • this product generally produces a bowel movement in 15 minutes to 1 hour
Dosage and Administration (34068-7)

Directions

  • tear off one suppository from the strip
  • peel apart the wrapper
  • continue peeling apart to almost the full length of the suppository (see illustration at the right)
  • gently remove the suppository from the wrapper
  • lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out
  • retain it for about 15 to 20 minutes.
  • Do not exceed recommended dose
  • if suppository seems soft, place in refrigerator for a short time before use

adults and children 12 years and over

1 suppository once daily
children under 12 years Ask a doctor

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at temperatures below 25 C (77F)
  • Made in India
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 50566-9 (50566-9)

Stop use and ask a doctor if

  • you have rectal bleeding or you fail to have bowel movement after using a laxative. These may be signs of a serious condition.
  • you need to use a laxative product for more than one week
Section 50567-7 (50567-7)

When using this product you may experience

  • rectal burning
  • mild cramps
  • abdominal discomfort
  • faintness
Section 50569-3 (50569-3)

Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period 2 weeks.

Section 50570-1 (50570-1)

Do not use

when abdominal pain, nausea, or vomiting are present.

Section 51727-6 (51727-6)

Inactive ingredient hard fat

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments? 1-800-540-3765

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stimulant Laxative

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:10.685899 · Updated: 2026-03-14T23:13:11.905913