Label at a glance#

ProductBISACODYL

Active ingredientBISACODYL

Label structure14 sections

Indications and uses

for relief of occasional constipation this product usually produces bowel movement in 1/4 to 1 hour

Dosage and administration

adults and children 12 years of age and older detach one suppository from the strip remove from wrapper before inserting into the rectum the rectal suppository dose is one suppository per day or as directed by a doctor children under 12 years of age consult a doctor

Label contents#

Full prescribing information#

Active Ingredients (per suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 10 mg

Purpose

OTC - PURPOSE SECTION

Laxative

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

for relief of occasional constipation
this product usually produces bowel movement in 1/4 to 1 hour

Warnings

WARNINGS SECTION

For rectal use only.

Do not use laxative products

OTC - DO NOT USE SECTION

when abdominal pain, nausea or vomiting are present
for a period longer than one week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

noticed a sudden change in bowel habits that persist over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older
detach one suppository from the strip
remove from wrapper before inserting into the rectum
the rectal suppository dose is one suppository per day or as directed by a doctor
children under 12 years of age consult a doctor

Other information

OTHER SAFETY INFORMATION

store below 30° C (86° F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Bisacodyl Laxative Suppositories_PDP

01b LBL_Bisacodyl Laxative Suppositories_DF box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68784-102-01	2021-05-18	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-08	2021-05-18	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-12	2021-05-18	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-16	2021-05-18	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-01	2020-01-31	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-08	2020-01-31	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-12	2020-01-31	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)
68784-102-16	2020-01-31	C162847	48780-1	9d75b9d0-9feb-f424-e053-dadaa90a57ce	ACINO - BISACODYL LAXATIVE SUPPOSITORIES (68784-102)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68784-102-12	EA - Each	68784-102	cbea6d32-e10f-4c6f-b3d4-c3d868f7cb1d	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	1
FAT, HARD	INACTIVE INGREDIENT	8334LX7S21	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

BISACODYL
FAT, HARD
DEACETYLBISACODYL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68784-102	68784-102-08, 68784-102-12, 68784-102-16, 68784-102-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FAT, HARD	8334LX7S21	IACT
BISACODYL	10X0709Y6I	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FAT, HARD	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
FAT, HARD	HARD FAT	8334LX7S21	CAPSULE / ORAL		153 mg	Exact identifier — unii candidate 2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f473f581-c449-25e0-e053-2a95a90adae5			eaef702c-3742-4aa2-875a-c7ffd7a98aa0	2023-02-11	Warnings	Exact identifier spl id: f473f581-c449-25e0-e053-2a95a90adae5 spl set id: eaef702c-3742-4aa2-875a-c7ffd7a98aa0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.