Label: RENASTAT- berberis vulgaris, petroselinum sativum, sabal serrulata, uva ursi, cantharis, lithium carbonicum, mercurius corrosivus liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 28, 2022

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  • ACTIVE INGREDIENTS:

    (in each drop): 16.60% of Cantharis 12X, Lithium Carbonicum 12X, Mercurius Corrosivus 12X, Pareira Brava 12X, Sarsaparilla 12X, Solidago Virgaurea 12X; 0.10% of Berberis Vulgaris 3X, Petroselinum Sativum 3X, Sabal Serrulata 3X, Uva Ursi 3X.

  • INDICATIONS:

    May temporarily relieve pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS:

    May temporarily relieve pain in the abdomen extending around to the back, pain in the thighs and loins on urinating and frequent urination.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • QUESTIONS

    Dist. by Energique, Inc.

    201 Apple Blvd

    Woodbine, IA 51579  800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    since 1987

    HOMEOPATHIC REMEDY

    RENASTAT

    1 fl. oz. (30 ml)

    Renastat

  • INGREDIENTS AND APPEARANCE
    RENASTAT 
    berberis vulgaris, petroselinum sativum, sabal serrulata, uva ursi, cantharis, lithium carbonicum, mercurius corrosivus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO3 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA12 [hp_X]  in 1 mL
    LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE12 [hp_X]  in 1 mL
    MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE12 [hp_X]  in 1 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
    PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM3 [hp_X]  in 1 mL
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) (ARCTOSTAPHYLOS UVA-URSI LEAF - UNII:3M5V3D1X36) ARCTOSTAPHYLOS UVA-URSI LEAF3 [hp_X]  in 1 mL
    CHONDRODENDRON TOMENTOSUM ROOT (UNII: 395A3P448Z) (CHONDRODENDRON TOMENTOSUM ROOT - UNII:395A3P448Z) CHONDRODENDRON TOMENTOSUM ROOT12 [hp_X]  in 1 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX ORNATA ROOT12 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0033-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/04/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/04/2012
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0033) , api manufacture(44911-0033) , label(44911-0033) , pack(44911-0033)