FDA.reportPublic FDA data

LAXATIVES RUBILAX

Manufacturer
Lydia Co., Ltd. | I World Pharmaceutical Co., Ltd.
Effective date
2023-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:04:44

Label at a glance#

ProductLAXATIVES RUBILAX
Active ingredientPSYLLIUM HUSK, SENNA PODS
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

psyllium husk powder, sennae fructus powder

INACTIVE INGREDIENT SECTION

lactose monohydrate, acacia, corn starch, carboxymethylcellulose calcium, l-menthol

OTC - PURPOSE SECTION

constipation

relieving the following symptoms of constipation: loss of appetite, abdominal distension, intestinal fermentation, hemorrhoids

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases

WARNINGS SECTION

do not administer to the following patients,

the product contains lactose, patients with rare hereditary problems of galactose intolerance, the lapp deficiency or glucose-galactose malabsorption should not take this medicine

DOSAGE & ADMINISTRATION SECTION

for oral use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72988-0010-22023-12-16C16284748780-1ba0f9c33-3b07-a910-e053-dadaa90a0b85Drug Facts
72988-0010-22021-01-29C16284748780-1ba0f9c33-3b07-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0010-1LAXATIVES RUBILAX3.5 g in 1 POUCHGRANULE3.52
72988-0010-2LAXATIVES RUBILAX30 in 1 POUCHGRANULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0010LAXATIVES RUBILAX (PSYLLIUM HUSKPOWDER) GRANULE [LYDIA CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20231217_87188d31-9fb1-5681-e053-2a91aa0a3022.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72988-001072988-0010-1, 72988-0010-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSYLLIUM HUSK0SHO53407GACTIB
LEVOMENTHOLBZ1R15MTK7IACT
SENNA PODSS8SJ19N2NXACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT

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
LAXATIVES RUBILAXPSYLLIUM HUSKPOWDERLydia Co., Ltd.87188d31-9fb1-5681-e053-2a91aa0a30222023-12-16WarningsExact identifier
ndc (package): 72988-0010-1
ndc (package): 72988-0010-2
ndc (product): 72988-0010
ndc11 (package): 72988001002
ndc11 (package): 72988001001
spl id: 0ca8aa27-d06b-cbe4-e063-6394a90a629f
spl set id: 87188d31-9fb1-5681-e053-2a91aa0a3022

Reported adverse events (FAERS/openFDA)#

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