Bisacodyl Usp suppositories 10 Mg

Bisacodyl Usp suppositories 10 Mg
SPL v3
SPL
SPL Set ID 03429da4-1ce9-4789-bf54-ce1b3215b013
Route
RECTAL
Published
Effective Date 2024-10-17
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 Completed Since 2023-08-24 Until 2026-10-31
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For rectal use only

Indications and Usage

Use

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

Directions

adults and children

12 years of age and over

1 suppository in a single daily dose. Peel open plastic. Insert suppository

well into rectum, pointed end first. Retain about 15 to 20 minutes
children 6 to under 12 years 1/2 suppository in a single daily dose
children under 6 years Do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
  • if suppository softens prior to use, may be placed in refrigerator for short time
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 need to use a laxative product for longer than one week
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
Section 50567-7

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

Section 50569-3

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks
Section 51727-6

Inactive ingredient hard fat

Section 51945-4

NDC 57237-327-21 (3 blisters of 4 suppositories)

Bisacodyl USP Suppositories 10 mg

Stimulant Laxative

Gentle, Predictable, Fast Relief

DO NOT SWALLOW

NDC 57237-327-04 (4 suppositories in 1 blister pack)

Front Foil

Back Foil

Section 53413-1

Questions or Comments? Call 1-844-474-7464

Section 53414-9

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

Section 55105-1

Purpose

Stimulant Laxative

Section 55106-9

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Section 60561-8

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

Structured Label Content

Indications and Usage (34067-9)

Use

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 15 minutes to 1 hour
Dosage and Administration (34068-7)

Directions

adults and children

12 years of age and over

1 suppository in a single daily dose. Peel open plastic. Insert suppository

well into rectum, pointed end first. Retain about 15 to 20 minutes
children 6 to under 12 years 1/2 suppository in a single daily dose
children under 6 years Do not use

Warnings and Precautions (34071-1)

Warnings

For rectal use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
  • if suppository softens prior to use, may be placed in refrigerator for short time
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 need to use a laxative product for longer than one week
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks
Section 51727-6 (51727-6)

Inactive ingredient hard fat

Section 51945-4 (51945-4)

NDC 57237-327-21 (3 blisters of 4 suppositories)

Bisacodyl USP Suppositories 10 mg

Stimulant Laxative

Gentle, Predictable, Fast Relief

DO NOT SWALLOW

NDC 57237-327-04 (4 suppositories in 1 blister pack)

Front Foil

Back Foil

Section 53413-1 (53413-1)

Questions or Comments? Call 1-844-474-7464

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stimulant Laxative

Section 55106-9 (55106-9)

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

Section 60561-8 (60561-8)

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND SUPPOSITORIES IS BROKEN OR MISSING

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.521886 · Updated: 2026-03-14T23:08:44.584027