Label: THYRO TONIC (chelidonium majus, spongia tosta, lac defloratum, fucus vesiculosus, hepar suis, hypophysis suis, thyroidinum (suis), calcarea carbonica, ferrum iodatum, iodium, kali iodatum, molybdenum, pulsatilla- pratensis 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 February 26, 2020

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  • ACTIVE INGREDIENTS:

    Chelidonium Majus 3X, Spongia Tosta 3X, Lac Defloratum 4X, 6X, 8X, Fucus Vesiculosus 6X, 12X, 30X, Hepar Suis 8X, Hypophysis Suis 8X, 12X, 100X, Thyroidinum (Suis) 8X, 12X, 100X, Calcarea Carbonica 12X, Ferrum Iodatum 12X, Iodium 12X, Kali Iodatum 12X, Molybdenum 12X, Pulsatilla (Pratensis) 12X.

  • INDICATIONS:

    For temporary relief of tightening of the throat, hoarseness, joints inflamed and painful and dry cough in evening and at night.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of tightening of the throat, hoarseness, joints inflamed and painful and dry cough in evening and at night.

  • INACTIVE INGREDIENTS:

    Gum Arabic Tree (Acacia Senegal) Powder, Borage Oil, Olive Oil, Sesame Oil

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    THYRO TONIC

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Thyro Tonic

  • INGREDIENTS AND APPEARANCE
    THYRO TONIC 
    chelidonium majus, spongia tosta, lac defloratum, fucus vesiculosus, hepar suis, hypophysis suis, thyroidinum (suis), calcarea carbonica, ferrum iodatum, iodium, kali iodatum, molybdenum, pulsatilla (pratensis) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0549
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 1 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK4 [hp_X]  in 1 mL
    FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS6 [hp_X]  in 1 mL
    PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER8 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND8 [hp_X]  in 1 mL
    THYROID, PORCINE (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) THYROID, PORCINE8 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
    FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN) FERROUS IODIDE12 [hp_X]  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE12 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION12 [hp_X]  in 1 mL
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM12 [hp_X]  in 1 mL
    ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI) ANEMONE PRATENSIS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    BORAGE OIL (UNII: F8XAG1755S)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SESAME OIL (UNII: QX10HYY4QV)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0549-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/26/2020
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0549) , api manufacture(43857-0549) , label(43857-0549) , pack(43857-0549)
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