Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 8336d821-ec70-468e-98b2-512a9a7212e0
Route
RECTAL
Published
Effective Date 2019-04-10
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 Size: 34 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-26
Description

Bisacodyl USP, 10 mg

Purpose

Stimulant Laxative

Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl USP, 10 mg

Uses
  • For relief of occasional constipation and irregularity
  • -This product generally produces bowel movement in 15 minutes to 1 hour

Section 50566-9

Stop use and ask a doctor if

  • if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate a serious condition
  • you need to use a laxative for more than 1 week
Section 50569-3
  • stomach pain, nausea or vomiting

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

Section 51945-4

Section 53414-9

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

Warnings
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 doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum

-Do not use more than once per day

Active Ingredient

Bisacodyl USP, 10 mg





Other Information
  •  do not store above 30°C (86°F)
Inactive Ingredients

hydrogenated vegetable oil

When Using This Product

May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses
  • For relief of occasional constipation and irregularity
  • -This product generally produces bowel movement in 15 minutes to 1 hour

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate a serious condition
  • you need to use a laxative for more than 1 week
Section 50569-3 (50569-3)
  • stomach pain, nausea or vomiting

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Stimulant Laxative

Warnings
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 doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum

-Do not use more than once per day

Active Ingredient (Active ingredient)

Bisacodyl USP, 10 mg





Other Information
  •  do not store above 30°C (86°F)
Inactive Ingredients

hydrogenated vegetable oil

When Using This Product (When using this product)

May cause abdominal discomfort, faintness, rectal burning, and mild cramps

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:54.421734 · Updated: 2026-03-14T23:06:01.213422