THYROPLEX- fucus vesiculosus, spongia tosta, iodium, liothyronine sodium, pulsatilla, glandula suprarenalis bovinum, pituitarum posterium, thyroidinum, calcarea carbonica, ferrum iodatum, kali iodatum, lycopus virginicus, phosphoricum acidum liquid
Apotheca Company

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: Fucus vesiculosus 3X, Spongia tosta 3X, Iodium 6X, Liothyronine sodium 6X, Pulsatilla 6X, 12X, 30X, Glandula suprarenalis bovinum 8X, Pituitarum posterium 8X, Thyroidinum 8X, 12X, 30X, 200X, Calcarea carbonica 12X, Ferrum iodatum 12X, Kali iodatum 12X, Lycopus virginicus 12X, Phosphoricum acidum 12X.

INDICATIONS: For temporary relief of exhaustion and heaviness of the body, lowered metabolism, cough, dry, croupy, difficulty swallowing, and swollen throat.

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 & USAGE:

For temporary relief of exhaustion and heaviness of the body, lowered metabolism, cough, dry, croupy, difficulty swallowing, and swollen throat.

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol

Distributed By:

BioActive Nutritional

Melbourne, FL 32935

For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

THYROPLEX

1 FL OZ (30 ML)

Thyroplex

THYROPLEX
fucus vesiculosus, spongia tosta, iodium, liothyronine sodium, pulsatilla, glandula suprarenalis bovinum, pituitarum posterium, thyroidinum, calcarea carbonica, ferrum iodatum, kali iodatum, lycopus virginicus, phosphoricum acidum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0328
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	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
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	6 [hp_X] in 1 mL
LIOTHYRONINE SODIUM (UNII: GCA9VV7D2N) (LIOTHYRONINE - UNII:06LU7C9H1V)	LIOTHYRONINE	6 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_X] in 1 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	200 [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
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29)	BOS TAURUS ADRENAL GLAND	8 [hp_X] in 1 mL
LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F)	LYCOPUS VIRGINICUS	12 [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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0328-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/11/2010	09/12/2016

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0328) , api manufacture(57520-0328) , label(57520-0328) , pack(57520-0328)

Revised: 8/2015

Document Id: cf10f829-2947-43fc-8d73-4797b13357f2

Set id: 11c0915f-2c0b-4c8e-a5b3-a8944735c079

Version: 2

Effective Time: 20150812

Apotheca Company