FDA.reportPublic FDA data

Bladder Irritation and UTI

Manufacturer
HomeoCare Laboratories, Inc.
Effective date
2019-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:08

Label at a glance#

ProductBladder Irritation and UTI
Active ingredientSERENOA REPENS WHOLE, PIPER CUBEBA FRUIT, CLEMATIS RECTA FLOWERING TOP, ARCTOSTAPHYLOS UVA-URSI LEAF, DELPHINIUM STAPHISAGRIA SEED, ECHINACEA ANGUSTIFOLIA, LYTTA VESICATORIA, RANUNCULUS BULBOSUS
Label structure8 sections

Indications and uses

Temporarily relieves burning sensation frequent urge to urinate painful urination inflammation

Dosage and administration

Adult and children 12 years and older: Under 12 consult a doctor. Slightly chew one tablet and allow to dissolve in the mouth, 3 times daily or up to 6 times daily for intense symptoms. Reduce to one tablet daily for 7 days after symptoms improve. Take at least 15mn apart from food and drinks

Label contents#

Full prescribing information#

Uses*

INDICATIONS & USAGE SECTION

Temporarily relieves

  • burning sensation
  • frequent urge to urinate
  • painful urination
  • inflammation

Directions:

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years and older:

Under 12 consult a doctor. Slightly chew one tablet and allow to dissolve in the mouth, 3 times daily or up to 6 times daily for intense symptoms. Reduce to one tablet daily for 7 days after symptoms improve. Take at least 15mn apart from food and drinks

Warnings

WARNINGS SECTION

If pregnant or breastfeeding, ask a health professional before use.

Stop use and ask a doctor if symptoms persist, worsen or reoccur, are severe, or if you experience fever, chills, back pain or bloody urine. Keep this and all medicinces out of the reach of children.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

lactose, dextrose, croscarmellose sodium, microcrystalline cellulose, magnesium stearate.

Questions, Comments?

OTC - QUESTIONS SECTION

www.homeocare.com - 1-888-HOMEOCARE

Manufactured by HomeoCare Labs, Yonkers NY

Drug Facts Active ingredients HPUS Purpose

OTC - ACTIVE INGREDIENT SECTION

Each 300-mg tablet contains equal parts of

Cantharis 6X......Bladder and urethra inflammation

Clematis 6X......Milky urine, burning sensation

Cubeba 6X......Blood in urine

Echinacea 6X......Pain and burning on urination

Ranunculus bulbosus 6X......Frequent urging to urinate

Sabal ser. 6X......Painful urination, scalding urine

Staphysagria 6X......Burning sensation in urethra

Uva ursi 6X......Painful urination, urging

Uses*

OTC - PURPOSE SECTION

Temporarily relieves

  • burning sensation
  • frequent urge to urinate
  • painful urination
  • inflammation

Bladder Irritation & UTI

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HCL-UTI 60 tabs.jpgHCL-UTI 60 tabs.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61727-353-60Bladder Irritation and UTI60 in 1 BOTTLETABLET, CHEWABLE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61727-353BLADDER IRRITATION AND UTI (CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI) TABLET, CHEWABLE [HOMEOCARE LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20190321_84796173-945d-c70b-e053-2991aa0a4ee1.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61727-35361727-353-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM STEARATE70097M6I30IACT
SERENOA REPENS WHOLE487DXM62F2ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
PIPER CUBEBA FRUITZ99L7429MAACTIB
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
DEXTROSEIY9XDZ35W2IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB

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
Bladder Irritation and UTICANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSIHomeoCare Laboratories, Inc.84796173-945d-c70b-e053-2991aa0a4ee12019-03-19WarningsExact identifier
ndc (package): 61727-353-60
ndc (product): 61727-353
ndc11 (package): 61727035360
spl id: 84796173-945e-c70b-e053-2991aa0a4ee1
spl set id: 84796173-945d-c70b-e053-2991aa0a4ee1

Reported adverse events (FAERS/openFDA)#

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