BISACODYL ENTERIC

Manufacturer
DIRECT RX
Effective date
2017-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:10

Label at a glance#

ProductBISACODYL ENTERIC
Active ingredientBISACODYL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5mg

WARNINGS SECTION

Do not use

Do not use if you cannot swallow without chewing

Ask a doctor before use if

-you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

When using this product

-do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

ask a health professions before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Stimulant laxative

INDICATIONS & USAGE SECTION

-relieves occasional constipation and irregularity

-this product generally produces bowel movement in 6 to 12 hours

DOSAGE & ADMINISTRATION SECTION

-take with a glass of water

adults and children 12 years and over- take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age - take 1 tablet in a single daily dose

children under 6 years of age - ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

-store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity

INACTIVE INGREDIENT SECTION


acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

085085

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-085-60EA - Each61919-0854f616995-3ce5-46c5-ae6f-cfe14256a58912019-08-06
0904-7927-17EA - Each0904-79277e7907ab-0977-40ec-a77a-d6f395a894a212013-02-13
0904-7927-60EA - Each0904-79273e50c02d-9513-47d5-bea0-f898f04891a712013-02-13
0904-7927-61EA - Each0904-7927856c9c8d-f029-4cdd-b96c-8f84d822b28d12013-02-13
0904-7927-80EA - Each0904-792793f3c97b-baac-4a58-b9d9-3d7f4876bfc412013-02-13

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61919-08561919-085-60
0904-7927

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0711a7f4-47e5-1b64-e063-6394a90ab703494943af-f999-4e24-e054-00144ff8d46c2023-10-06WarningsExact identifier
spl set id: 494943af-f999-4e24-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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