Label: HTHY (calcarea carbonica, calcarea iodata, ferrum iodatum, fucus vesiculosus, hepar sulphuris calcareum, kali iodatum, lapis albus calcium fluosilicate, oryctolagus cuniculus (rabbit) adrenal gland, oryctolagus cuniculus (rabbit) pituitary gland, oryctolagus cuniculus (rabbit) spleen, oryctolagus cuniculus (rabbit) thymus gland, oryctolagus cuniculus- rabbit thyroid gland, spongia tosta 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 January 30, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Each drop contains:
    Calcarea carbonica 8X
    Calcarea iodata 4X
    Ferrum iodatum 6X
    Fucus vesiculosus (Bladderwrack) Thallus 6X
    Hepar sulphuris calcareum 8X
    Kali iodatum 6X
    Lapis albus (Gastein rock) Calcium Fluosilicate 6X
    Oryctolagus cuniculus (Rabbit) Adrenal Gland 10X
    Oryctolagus cuniculus (Rabbit) Pituitary Gland 10X

    Oryctolagus cuniculus (Rabbit) Spleen 10X
    Oryctolagus cuniculus (Rabbit) Thymus Gland 10X

    Oryctolagus cuniculus (Rabbit) Thyroid Gland 10X
    Spongia tosta (Roasted Sponge) 6X

  • PURPOSE

    Uses

    Helps promote and maintain normal metabolic functions.

  • WARNINGS

    Warnings
    Stop use and ask a doctor if symptoms persist or worsen.
    If pregnant or breastfeeding, 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.

    Contains: Shellfish (oyster)

  • STOP USE

    Stop use and ask a doctor if symptoms persist or worsen.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • OTHER SAFETY INFORMATION

    Other information

    Store in a cool, dry place.

    Use only if safety seal is intact.

    Contents may not fill package in order to accommodate required labeling. Please rely on stated quantity.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ethanol (beet), purified water

  • DOSAGE & ADMINISTRATION

    Directions

    To be taken 20 minutes away from food.

    Place drops directly under the tongue or into ¼ oz of water.

    Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended
    by your healthcare practitioner.

    Children (under 12 years): Take under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses

    Helps promote and maintain normal metabolic functions.

    Directions

    To be taken 20 minutes away from food.

    Place drops directly under the tongue or into ¼ oz of water.

    Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended
    by your healthcare practitioner.

    Children (under 12 years): Take under the direction of your healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    Genestra Brands

    NDC 62106-0631-0

    HTHY

    HOMEOPATHIC PREPARATION

    To help promote and maintain normal metabolic functions.

    Contains 31% Alcohol

    1 fl oz (30 mL)

    HTHY PDP HTHY cont

  • INGREDIENTS AND APPEARANCE
    HTHY 
    calcarea carbonica, calcarea iodata, ferrum iodatum, fucus vesiculosus, hepar sulphuris calcareum, kali iodatum, lapis albus calcium fluosilicate, oryctolagus cuniculus (rabbit) adrenal gland, oryctolagus cuniculus (rabbit) pituitary gland, oryctolagus cuniculus (rabbit) spleen, oryctolagus cuniculus (rabbit) thymus gland, oryctolagus cuniculus (rabbit) thyroid gland, spongia tosta liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-0631
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE8 [hp_X]  in 30 mL
    CALCIUM IODIDE (UNII: 8EKI9QEE2H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM IODIDE4 [hp_X]  in 30 mL
    FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN) FERROUS IODIDE6 [hp_X]  in 30 mL
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS6 [hp_X]  in 30 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE8 [hp_X]  in 30 mL
    CALCIUM HEXAFLUOROSILICATE (UNII: 2NVP93XVQ3) (CALCIUM HEXAFLUOROSILICATE - UNII:2NVP93XVQ3) CALCIUM HEXAFLUOROSILICATE6 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS ADRENAL GLAND (UNII: QGY289M89Q) (ORYCTOLAGUS CUNICULUS ADRENAL GLAND - UNII:QGY289M89Q) ORYCTOLAGUS CUNICULUS ADRENAL GLAND10 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS PITUITARY GLAND (UNII: T9F9ZW799A) (ORYCTOLAGUS CUNICULUS PITUITARY GLAND - UNII:T9F9ZW799A) ORYCTOLAGUS CUNICULUS PITUITARY GLAND10 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS SPLEEN (UNII: 01WNS05SFO) (ORYCTOLAGUS CUNICULUS SPLEEN - UNII:01WNS05SFO) ORYCTOLAGUS CUNICULUS SPLEEN10 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS THYMUS (UNII: 7ZO132YX2X) (ORYCTOLAGUS CUNICULUS THYMUS - UNII:7ZO132YX2X) ORYCTOLAGUS CUNICULUS THYMUS10 [hp_X]  in 30 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_X]  in 30 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE6 [hp_X]  in 30 mL
    ORYCTOLAGUS CUNICULUS THYROID (UNII: 97K9E28344) (ORYCTOLAGUS CUNICULUS THYROID - UNII:97K9E28344) ORYCTOLAGUS CUNICULUS THYROID10 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-0631-01 in 1 CARTON11/27/2015
    130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/27/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-0631)
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