Gentle Laxative

Manufacturer
CARDINAL HEALTH | Geri-Care Pharmaceutical Corp
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:28

Label at a glance#

ProductGentle Laxative
Active ingredientBISACODYL
Label structure8 sections

Indications and uses

for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hour

Dosage and administration

take with a glass of water adults and children 12 years and older: take 1 to 3 tablets in a single daily dose children 12 years and under: ask a doctor

Storage and handling

Tamper Evident: Do not use if imprinted seal under cap is missing or broken store at room temperature avoid excessive humidity

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hour

Warnings

WARNINGS SECTION

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have

  • stomach pain, nausea, vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

When using this product

  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product.

These could be signs of a serious condition.

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

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

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 years and under: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature
  • avoid excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN5
308753bisacodyl 5 MG Delayed Release Oral TabletSCD5
308753bisacodyl 5 MG Enteric Coated Oral TabletSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0538-1Gentle Laxative100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0538GENTLE LAXATIVE (BISACODYL) TABLET [CARDINAL HEALTH]5Current NDC, Legacy NDC, 1 package rows20231207_97b83b7a-1a41-71e7-e053-2995a90ac640.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0538-1EA - Each70000-053858274d1b-f6e6-419e-bcff-67b3180961b912020-04-20

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-053870000-0538-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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
Gentle LaxativeBISACODYLCARDINAL HEALTH97b83b7a-1a41-71e7-e053-2995a90ac6402023-12-06WarningsExact identifier
ndc (package): 70000-0538-1
ndc (product): 70000-0538
ndc11 (package): 70000053801
spl id: 0bdcdd75-0629-bd6b-e063-6394a90a6d38
spl set id: 97b83b7a-1a41-71e7-e053-2995a90ac640

Reported adverse events (FAERS/openFDA)#

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