FDA.reportPublic FDA data

Laxomil

Manufacturer
Pharmadel LLC
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:00

Label at a glance#

ProductLaxomil
Active ingredientBISACODYL
Label structure9 sections

Dosage and administration

take with plenty of water do not chew or crush tablet(s) Age Dose adults and children 12 years and older take 1 to 3 tablets in a single dose, once a day children 6 to undee 12 years take 1 tablet once a day children under 6 years consult a doctor

Label contents#

Full prescribing information#

Active ingredients and Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientes (in each tablet) Purpose
Bisacodyl 5 mg .........Stimulant laxative

Use

INDICATIONS & USAGE SECTION

For relief of occasional constipation (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. These tablets should not be chewed because gastric irritation may occur.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

  • take this product 2 hours before or after other drugs
  • do not take this product within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use for more than 7 days
  • rectal bleeding occurs
  • you fail to have a bowel movement after use of 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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with plenty of water
  • do not chew or crush tablet(s)
AgeDose
adults and children 12 years and older take 1 to 3 tablets in a single dose, once a day
children 6 to undee 12 years take 1 tablet once a day
children under 6 yearsconsult a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 68-77°F (20-25°C)
  • do not use if seal under cap is torn, broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow #10, FD&C yellow #6, hypromellose, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide,triethyl citrate, water

Questions?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist. by/ por:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

www.pharmadel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP LAXOMILPDP LAXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN2
2719716Laxomil 5 MG Delayed Release Oral TabletPSN2
2719716bisacodyl 5 MG Delayed Release Oral Tablet [Laxomil]SBD2
308753bisacodyl 5 MG Delayed Release Oral TabletSCD2
308753bisacodyl 5 MG Enteric Coated Oral TabletSY2
2719716Laxomil 5 MG Delayed Release Oral TabletSY2

DailyMed Pharmacologic Classes#

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

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
55758-504-01Laxomil1 in 1 CARTONTABLET, COATED12
55758-504-01Laxomil24 in 1 BLISTER PACKTABLET, COATED242

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-50455758-504-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BISACODYL10X0709Y6IACTIB
WATER059QF0KO0RIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
METHACRYLIC ACID1CS02G8656IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT

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
LaxomilBISACODYL 5MGPharmadel LLC3999935b-d8e8-52a6-e063-6294a90aa2a22026-03-20WarningsExact identifier
ndc (package): 55758-504-01
ndc (product): 55758-504
ndc11 (package): 55758050401
spl id: 4d7abf05-8f42-a9a5-e063-6394a90a579d
spl set id: 3999935b-d8e8-52a6-e063-6294a90aa2a2

Reported adverse events (FAERS/openFDA)#

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