FDA.reportPublic FDA data

Vegetable Laxative

Manufacturer
Granulation Technology, Inc.
Effective date
2025-07-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:08:56

Label at a glance#

ProductVegetable Laxative
Active ingredientSENNOSIDES
Label structure12 sections

Indications and uses

Relieves occasional constipation (irregularity) Generally produces a bowel movement in 6-12 hours

Dosage and administration

Take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides                       8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

OTC - WHEN USING SECTION

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours

Do not use

OTC - DO NOT USE SECTION

  • Laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that continues over a period of 2 weeks

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take preferably at bedtime or as directed by a doctor
agestarting dosagemaximum dosage
adults and children
12 years of age and over 		2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

HOW SUPPLIED SECTION

  • Each tablet contains:Calcium 27.93 mg
  • Store between 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol (PEG) 4000, talc

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63561-0188-01

Vegetable Laxative Label

SENNOSIDES, 8.6 mg LAXATIVE

Compare to Senokot ® Regular Strength Active Ingredients

100 Film-Coated Tablets

btl-label-senno8.6mg-100sbtl-label-senno8.6mg-100s

btl-label-senno8.6mg-100s-peelbtl-label-senno8.6mg-100s-peel

NDC 63561-0188-02

Vegetable Laxative Label

SENNOSIDES, 8.6 mg LAXATIVE

Compare to Senokot ® Regular Strength Active Ingredients

1000 Film-Coated Tablets

btl-label-senno8.6mg-1000sbtl-label-senno8.6mg-1000s

btl-label-senno8.6mg-1000s-peelbtl-label-senno8.6mg-1000s-peel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN4
312935sennosides, USP 8.6 MG Oral TabletSCD4
312935sennosides A and B 8.6 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0188-1Vegetable Laxative100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
63561-0188-2Vegetable Laxative1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10004

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63561-018863561-0188-1, 63561-0188-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL532B59J990IACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
TALC7SEV7J4R1UIACT
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT

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
Vegetable LaxativeSENNOSIDES, 8.6 MGGranulation Technology, Inc.63dfe908-7cc0-41ca-9739-4b24ee14648e2025-07-30WarningsExact identifier
ndc (package): 63561-0188-2
ndc (package): 63561-0188-1
ndc (product): 63561-0188
ndc11 (package): 63561018801
ndc11 (package): 63561018802
spl id: 3b297015-438b-9914-e063-6294a90adc3a
spl set id: 63dfe908-7cc0-41ca-9739-4b24ee14648e

Reported adverse events (FAERS/openFDA)#

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