Drug Facts

Drug Labeling and Warnings

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THYRO TONIC- chelidonium majus, spongia tosta, lac defloratum, fucus vesiculosus, hepar suis, pituitary (suis), thyroidinum (suis), calcarea carbonica, ferrum iodatum, iodium, kali iodatum, molybdenum metallicum, pulsatilla, 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, Pituitary (suis) 8X, 12X, 100X, Thyroidinum (suis) 8X, 12X, 100X, Calcarea carbonica 12X, Ferrum iodatum 12X, Iodium 12X, Kali iodatum 12X, Molybdenum metallicum 12X, Pulsatilla 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.

DIRECTIONS:   Shake Well Before Use.   10 drops orally, 3 times a day.  Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:  Acacia arabica (gum), Borage oil, Demineralized water, 25% Ethanol, Olive oil, Sesame oil.

KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.

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

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

THYRO TONIC

1 FL OZ

THYRO TONIC 
chelidonium majus, spongia tosta, lac defloratum, fucus vesiculosus, hepar suis, pituitary (suis), thyroidinum (suis), calcarea carbonica, ferrum iodatum, iodium, kali iodatum, molybdenum metallicum, pulsatilla, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0026
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	8 [hp_X]  in 1 mL
THYROID, PORCINE (UNII: 6RV024OAUQ) (THYROID, PORCINE - 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)	POTASSIUM IODIDE	12 [hp_X]  in 1 mL
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U)	MOLYBDENUM	12 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0026-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/14/2012	08/27/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0026) , api manufacture(43857-0026) , label(43857-0026) , pack(43857-0026)

Revised: 5/2015

Document Id: 9159c6fe-2ffe-45a7-92aa-7158590ccd52

Set id: dd166275-c87b-4d59-acd1-987948413b4a

Version: 3

Effective Time: 20150521