URODEL HOMEOPATHIC URINARY TRACT INFECTION (CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI) TABLET, CHEWABLE [PHARMADEL LLC]

URODEL HOMEOPATHIC URINARY TRACT INFECTION (CANTHARIS, CLEMATIS, CUBEBA, ECHINACEA, RANUNCULUS BULBOSUS, SABAL SER, STAPHYSAGRIA, UVA URSI) TABLET, CHEWABLE [PHARMADEL LLC]
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NDC 55758-308-30, 55758-308-60
Set ID 81dfb974-e96b-caba-e053-2a91aa0ab7f4
Category HUMAN OTC DRUG LABEL
Packager Pharmadel LLC
Generic Name
Product Class
Product Number
Application Number
  • Drug Facts

  • Active Ingredients & Purposes

    Active ingredients**.....................................

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

    Purposes*


    Cantharis 6X HPUS......................................Bladder and urethra inflammation
    Clematis 6X HPUS........................................Milky urine, burning sensation
    Cubeba 6X HPUS..........................................Blood in urine
    Echinacea 6X HPUS......................................Pain and burning on urination
    Ranunculus bulbosus 6X HPUS.................Frequent urging to urinate
    Sabal ser. 6X HPUS........................................Painful urination, scalding urine
    Staphysagria 6X HPUS..................................Burning sensation in urethra
    Uva ursi 6X HPUS............................................Painful urination, urging

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

  • Uses*

    Temporarily relieves symptoms associated with urinary tract infections

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

    Stop use and ask a doctor if

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

    If pregnant or breastfeeding,

    ask a health professional before use.

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

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

  • Directions:

    • 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

    • 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

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

  • Questions & comments?

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

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Carton

    Urodel

    Urinary Tract Infection

    SYMPTOMS RELIEF

    • Frequent urge to urinate
    • Bladder inflammation
    • Burning or painful urination

    HOMEOPATHIC
    30 chewable tablets

    URODEL

  • PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton

    Urodel

    Urinary Tract Infection

    SYMPTOMS RELIEF

    Frequent urge to urinate
    Bladder inflammation
    Burning or painful urination

    HOMEOPATHIC
    60 chewable tablets

    URODEL 60

  • INGREDIENTS AND APPEARANCE
    URODEL HOMEOPATHIC URINARY TRACT INFECTION 
    cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal ser, staphysagria, uva ursi tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-308
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F) CLEMATIS RECTA FLOWERING TOP6 [hp_X]
    PIPER CUBEBA FRUIT (UNII: Z99L7429MA) (PIPER CUBEBA FRUIT - UNII:Z99L7429MA) PIPER CUBEBA FRUIT6 [hp_X]
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_X]
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF6 [hp_X]
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS6 [hp_X]
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO6 [hp_X]
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED6 [hp_X]
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White Tablet) Scoreno score
    ShapeOVAL (Clear capsule) Size10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-308-301 in 1 CARTON01/08/2018
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55758-308-601 in 1 CARTON01/08/2018
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/08/2018
    Labeler - Pharmadel LLC (030129680)

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