FDA.reportPublic FDA data

Laxative - HHH Pharmaceuticals

Manufacturer
HHH Pharmaceuticals
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:05

Label at a glance#

ProductLaxative
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

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

Dosage and administration

take with a glass of water adults and children 12 years of age and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years   1 tablets once a day children under 6 years  ask a doctor

Storage and handling

store at controlled room temperature 20°-25°C (68°-77°F) read all product information before use.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 5 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you cannot swallow without chewing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 of age and overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 years  1 tablets once a day
children under 6 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

Questions or comments?

OTC - QUESTIONS SECTION

Call + 1-848-235-5293

Monday through Friday 9AM – 5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN2
308753bisacodyl 5 MG Delayed Release Oral TabletSCD2
308753bisacodyl 5 MG Enteric Coated Oral TabletSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130383586116014GTIN-13: 0383586116014
EAN-13: 0383586116014
GTIN-12: 383586116014
UPC-A: 383586116014
GTIN storage (14 digits): 00383586116014		label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83586-116-01Laxative100 in 1 BOTTLETABLET, DELAYED RELEASE1002

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83586-11683586-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
METHACRYLIC ACID1CS02G8656IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
BISACODYL10X0709Y6IACTIB

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
LaxativeBISACODYLHHH Pharmaceuticalsafb39544-c509-490c-ad42-ba68ebbf986b2026-05-06WarningsExact identifier
ndc (package): 83586-116-01
ndc (product): 83586-116
ndc11 (package): 83586011601
spl id: 511f595c-287d-c966-e063-6294a90a96d6
spl set id: afb39544-c509-490c-ad42-ba68ebbf986b

Reported adverse events (FAERS/openFDA)#

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