FDA.reportPublic FDA data

Urodel Homeopathic Urinary Tract Infection

Manufacturer
Pharmadel LLC
Effective date
2022-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:43:09

Label at a glance#

ProductUrodel Homeopathic Urinary Tract Infection
Active ingredientCLEMATIS RECTA FLOWERING TOP, PIPER CUBEBA FRUIT, ECHINACEA ANGUSTIFOLIA, ARCTOSTAPHYLOS UVA-URSI LEAF, RANUNCULUS BULBOSUS, SAW PALMETTO, DELPHINIUM STAPHISAGRIA SEED, LYTTA VESICATORIA
Label structure8 sections

Indications and uses

Temporarily relieves symptoms associated with urinary tract infections burning sensation when urinating frequent urge to urinate painful urination bladder inflammation

Dosage and administration

adult and children 12 years of age and older: 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 15 minutes prior to eating food or drinking. children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active Ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients** (HPUS)

(in each 300 mg tablet contains equal parts of:)

Purposes*

Cantharis vesicatoria 6X .....................

Sharp burning pain during urination

Clematis erecta 6X ...............................

Burning sensation

Cubeba officinalis 6X .............................

Frequent urination, yellow discharge

Echinacea angustifolia 6X .....................

Bladder inflammation

Ranunculus bulbosus 6X ......................Frequent urging to urinate
Sabal serrulata 6X ........................................Painful urination
Staphysagria 6X ..................................

Pressure on the bladder

Uva ursi 6X ............................................

Constant urination and straining

The letters HPUS indicate that this ingredient is officially included in the homeopathic Pharmacopeia of the United States.

Uses*

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms associated with urinary tract infections

  • burning sensation when urinating
  • frequent urge to urinate
  • painful urination
  • bladder inflammation

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • symptoms persist, worsen, reoccur or are severe
  • you experience fever, chills, back pain, or bloody urine
  • an allergic reaction occurs, seek medical help right away

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep this and all medicines out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adult and children 12 years of age and older: 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 15 minutes prior to

eating food or drinking.

  • children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 59°-86°F (15°-30°C) and protect from light
  • do not use if seal is torn, broken, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions & comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Urodel PDPUrodel PDP

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
55758-30855758-308-30, 55758-308-60

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
CLEMATIS RECTA FLOWERING TOP396421SP9FACTIB
PIPER CUBEBA FRUITZ99L7429MAACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB
SAW PALMETTOJ7WWH9M8QSACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
DEXTROSEIY9XDZ35W2IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT

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
0428288d-4064-e853-e063-6294a90adb0c81dfb974-e96b-caba-e053-2a91aa0ab7f42023-01-01WarningsExact identifier
spl set id: 81dfb974-e96b-caba-e053-2a91aa0ab7f4

Reported adverse events (FAERS/openFDA)#

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