Bisacodyl Enteric Coated Tablet

Manufacturer
REMEDYREPACK INC.
Effective date
2019-05-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:23:23

Label at a glance#

ProductBisacodyl Enteric Coated
Active ingredientBISACODYL
Label structure9 sections

Dosage and administration

 -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

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

 Bisacodyl 5mg

Purpose

OTC - PURPOSE SECTION

 Stimulant laxative

Use(s)

INDICATIONS & USAGE SECTION

 -relieves occasional constipation and irregularity

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

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

Do not use

OTC - DO NOT USE SECTION

 Do not use if you cannot swallow without chewing

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

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

-stomach pain, nausea or vomiting

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

 -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

OTC - STOP USE SECTION

 -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

OTC - PREGNANCY OR BREAST FEEDING SECTION

 ask a health professions before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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

Other information

SPL UNCLASSIFIED 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 ingredients

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.

Questions

OTC - QUESTIONS SECTION

 To Report Adverse Drug Event call: (800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: BisacodylEnteric Coated Enteric Coated

GENERIC: Bisacodyl

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-0662-0

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 5

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • BISACODYL 5mg in 1

INACTIVE INGREDIENT(S):

  • ACACIA
  • AMMONIUM NONOXYNOL-4 SULFATE
  • CELLULOSE, MICROCRYSTALLINE
  • SHELLAC
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • TITANIUM DIOXIDE
  • STEARIC ACID
  • TALC
  • ANHYDROUS LACTOSE
  • CALCIUM SULFATE ANHYDROUS
  • CARNAUBA WAX
  • GELATIN
  • Polyvinyl Acetate Phthalate
  • D&C YELLOW NO. 10
  • FD&C YELLOW NO. 6
  • SILICON DIOXIDE
  • STARCH, CORN

Remedy_LabelRemedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
70518-066270518-0662-0
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
a495bf41-709c-cba8-e053-2995a90a291f51bbe2e8-fd0a-468c-8ef0-28f6df270b632020-05-01WarningsExact identifier
spl set id: 51bbe2e8-fd0a-468c-8ef0-28f6df270b63

Reported adverse events (FAERS/openFDA)#

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