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
BioActive Nutritional, Inc.

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.

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DRUG FACTS:

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0549
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	3 [hp_X] in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_X] in 1 mL
SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A)	SKIM MILK	4 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	6 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	8 [hp_X] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	8 [hp_X] in 1 mL
THYROID, PORCINE (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	THYROID, PORCINE	8 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X] in 1 mL
FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN)	FERROUS IODIDE	12 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	12 [hp_X] in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	12 [hp_X] in 1 mL
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U)	MOLYBDENUM	12 [hp_X] in 1 mL
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	ANEMONE PRATENSIS	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
BORAGE OIL (UNII: F8XAG1755S)
OLIVE OIL (UNII: 6UYK2W1W1E)
SESAME OIL (UNII: QX10HYY4QV)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0549-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/26/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0549) , api manufacture(43857-0549) , label(43857-0549) , pack(43857-0549)