drug facts

drug facts

SPL v1

SPL

SPL Set ID 75133e10-f290-42be-be50-029b1367a35f

Route

rectal

Published

Effective Date 2010-03-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

bisacodyl (10 mg)

Inactive Ingredients

fat, hard

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2008-03-08

Purpose

Stimulant Laxative

Description

Bisacodyl, 10 mg

Medication Information

Warnings and Precautions

Warnings

For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Uses

For relief of occasional constipation
This product generally produces bowel movement in 15 minutes to 1 hour

Purpose

Stimulant Laxative

Directions

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

Detach one suppository from the strip and remove from foil
Carefully insert one suppository well into the rectum
Do not use more than once per day

Other Information

Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
Individually sealed for your protection. Do not use if foil is torn or open.

Description

Bisacodyl, 10 mg

Section 42229-5

Section 50567-7

Section 50568-5

Section 53413-1

Section 53414-9

Do Not Use

more than one 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
if seal under product lid is torn, damaged, or open

Inactive Ingredient

hydrogenated vegetable oil

Package Information

The Medicine Shoppe®

COMPARE TO ACTIVE INGREDIENT OF DULCOLAX®*

NDC 49614-133-35

Gentle Laxative

BISACODYL SUPPOSITORIES

CONSTIPATION RELIEF

8 SUPPOSITORIES 10 MG EACH

FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN PAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

*This product is not manufactured or distributed by Boehringer Ingelhem

Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.

Another Quality Product

Distributed by Medicine Shoppe Int'l., Inc.

St. Louis, MO 63132

www.medicineshoppe.com

A Cardinal Health Company

Ask A Doctor Before Use

if you have noticed a sudden change in bowel habits that persist over a period of two weeks
if you are pregnant or nursing a baby

Stop Use and Ask A Doctor

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Keep Out of Reach of Children

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

Active Ingredient (in Each Suppository)

Bisacodyl, 10 mg

Structured Label Content

Warnings and Precautions (34071-1)

Warnings (WARNINGS)

For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Uses (USES)

For relief of occasional constipation
This product generally produces bowel movement in 15 minutes to 1 hour

Purpose (PURPOSE)

Stimulant Laxative

Directions (DIRECTIONS)

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

Detach one suppository from the strip and remove from foil
Carefully insert one suppository well into the rectum
Do not use more than once per day

Other Information (OTHER INFORMATION)

Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F).
Individually sealed for your protection. Do not use if foil is torn or open.

Section 42229-5 (42229-5)

Section 50567-7 (50567-7)

Section 50568-5 (50568-5)

Section 53413-1 (53413-1)

Section 53414-9 (53414-9)

Do Not Use (Do not use)

more than one 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
if seal under product lid is torn, damaged, or open

Inactive Ingredient (INACTIVE INGREDIENT)

hydrogenated vegetable oil

Package Information (PACKAGE INFORMATION)

The Medicine Shoppe®

COMPARE TO ACTIVE INGREDIENT OF DULCOLAX®*

NDC 49614-133-35

Gentle Laxative

BISACODYL SUPPOSITORIES

CONSTIPATION RELIEF

8 SUPPOSITORIES 10 MG EACH

Another Quality Product

Distributed by Medicine Shoppe Int'l., Inc.

St. Louis, MO 63132

www.medicineshoppe.com

A Cardinal Health Company

Ask A Doctor Before Use (Ask a doctor before use)

if you have noticed a sudden change in bowel habits that persist over a period of two weeks
if you are pregnant or nursing a baby

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

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.

Active Ingredient (in Each Suppository) (ACTIVE INGREDIENT (in each suppository))

Bisacodyl, 10 mg

Advanced Ingredient Data

[{"name": "bisacodyl", "unii": "10X0709Y6I", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "fat, hard", "unii": "8334LX7S21", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "For relief of occasional constipation This product generally produces bowel movement in 15 minutes to 1 hour", "PURPOSE": "Stimulant Laxative", "WARNINGS": "For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.", "DIRECTIONS": "Adults and children 12 years of age and older One suppository once daily Children 6 to 12 years 1/2 suppository once daily Children under 6 Ask a doctor Detach one suppository from the strip and remove from foil Carefully insert one suppository well into the rectum Do not use more than once per day", "Do not use": "more than one 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 if seal under product lid is torn, damaged, or open", "OTHER INFORMATION": "Store at room temperature: 15°- 30° C (59° - 86° F). Do not exceed 30° C (86° F). Individually sealed for your protection. Do not use if foil is torn or open.", "INACTIVE INGREDIENT": "hydrogenated vegetable oil", "PACKAGE INFORMATION": "The Medicine Shoppe® COMPARE TO ACTIVE INGREDIENT OF DULCOLAX®* NDC 49614-133-35 Gentle Laxative BISACODYL SUPPOSITORIES CONSTIPATION RELIEF 8 SUPPOSITORIES 10 MG EACH FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN PAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN. *This product is not manufactured or distributed by Boehringer Ingelhem Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®. Another Quality Product Distributed by Medicine Shoppe Int'l., Inc. St. Louis, MO 63132 www.medicineshoppe.com A Cardinal Health Company", "Ask a doctor before use": "if you have noticed a sudden change in bowel habits that persist over a period of two weeks if you are pregnant or nursing a baby", "Stop use and ask a doctor": "if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away.", "ACTIVE INGREDIENT (in each suppository)": "Bisacodyl, 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.996693 · Updated: 2026-03-14T22:52:19.062647