Label: REHYDRATE JR.- avena sativa, equisetum hyemale, hypericum perforatum, ulmus fulva, glycyrrhiza glabra, glycyrrhiza glabra, pueraria lobata, aqua sulis, carlsbad aqua, adenosinum triphosphoricum dinatrum, germanium sesquioxide, hydrogen, oxygenium, wiesbaden liquid

  • NDC Code(s): 54638-0004-1
  • Packager: ParaDocs All Natural, Inc.
  • 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 March 11, 2020

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  • ACTIVE INGREDIENTS:

    Avena Sativa 3X, Equisetum Hyemale 4X, Hypericum Perforatum 6X, Ulmus Fulva 6X, Glycyrrhiza Glabra 12X, Pueraria Lobata 12X, Aqua Sulis 12C, Carlsbad Aqua 12C, Adenosinum Triphosphoricum Dinatrum 30C, Germanium Sesquioxide 30C, Hydrogen 3C, Oxygenium 30C, Wiesbaden 30C.

  • INDICATIONS:

    To aid with proper hydration.

  • 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.

  • 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.

  • DIRECTIONS:

    One drop per ounce of pure water. Consult a physician for use in children under 6 years of age.

  • INDICATIONS:

    To aid with proper hydration.

  • INACTIVE INGREDIENTS:

    Demineralized Water, Ethanol 1%, Glycerin, Proprietary Extract Blend of Beet (Root), Blessed Thistle (Aerial Parts), Boldo (Leaf), Celandine (Aerial Parts), Dandelion (Root), Parsley (Leaf).

  • QUESTIONS:

    MFD. FOR:

    ParaDocs All Natural Inc.

    2640 E. Oakland Park Blvd.

    Ft. Lauderdale, FL 33306

  • PACKAGE LABEL DISPLAY:

    ReHydrateJr.

    Homeopathic

    2 FL OZ (60 ml)

    ReHydrate Jr.

  • INGREDIENTS AND APPEARANCE
    REHYDRATE JR. 
    avena sativa, equisetum hyemale, hypericum perforatum, ulmus fulva, glycyrrhiza glabra, glycyrrhiza glabra, pueraria lobata, aqua sulis, carlsbad aqua, adenosinum triphosphoricum dinatrum, germanium sesquioxide, hydrogen, oxygenium, wiesbaden liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54638-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 1 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE4 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM6 [hp_X]  in 1 mL
    ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q) ULMUS RUBRA BARK6 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA12 [hp_X]  in 1 mL
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) (PUERARIA MONTANA VAR. LOBATA ROOT - UNII:PET93F4I3C) PUERARIA MONTANA VAR. LOBATA ROOT12 [hp_X]  in 1 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER12 [hp_C]  in 1 mL
    ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE DISODIUM30 [hp_C]  in 1 mL
    GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE30 [hp_C]  in 1 mL
    HYDROGEN (UNII: 7YNJ3PO35Z) (HYDROGEN - UNII:7YNJ3PO35Z) HYDROGEN30 [hp_C]  in 1 mL
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BEET (UNII: N487KM8COK)  
    CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N)  
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O)  
    CHELIDONIUM MAJUS FLOWERING TOP (UNII: O9HP59XU7F)  
    TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)  
    PARSLEY (UNII: 58FMD0Q0EV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54638-0004-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/11/2020
    Labeler - ParaDocs All Natural, Inc. (008540744)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(54638-0004) , api manufacture(54638-0004) , label(54638-0004) , pack(54638-0004)
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