UNIVERSALTOX- alfalfa, avena sativa, fucus vesiculosus, hordeum vulgare, nasturtium aquaticum, raphanus sativus, triticum aestivum, iodium, ubidecarenonum, glandula suprarenalis suis, hepar suis, manganese gluconate, oryza sativa, thyroidinum (suis), calcarea carbonica, natrum muriaticum, pulsatilla (pratensis), rhus tox, cortisone aceticum 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:

Alfalfa 3X, Avena Sativa 3X, Fucus Vesiculosus 4X, Hordeum Vulgare 4X, Nasturtium Aquaticum 4X, Raphanus Sativus 4X, Triticum Aestivum 4X, Iodium 6X, Ubiquinone 6X, Glandula Suprarenalis Suis 8X, Hepar Suis 8X, Manganum Gluconate 8X, Oryza Sativa 8X, Thyroidinum (Suis) 8X, Calcarea Carbonica 12X, Natrum Muriaticum 12X, Pulsatilla (Pratensis) 12X, Rhus Tox 12X, Cortisone Aceticum 30X.

INDICATIONS:

For temporary relief of sinus congestion, dry cough in the evening and rhinitis.

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 sinus congestion, dry cough in the evening and rhinitis.

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE DISPLAY LABEL:

BIOActive Nutritional

UNIVERSALTOX

HOMEOPATHIC

1 FL OZ (30 ml)

Universaltox

UNIVERSALTOX
alfalfa, avena sativa, fucus vesiculosus, hordeum vulgare, nasturtium aquaticum, raphanus sativus, triticum aestivum, iodium, ubidecarenonum, glandula suprarenalis suis, hepar suis, manganese gluconate, oryza sativa, thyroidinum (suis), calcarea carbonica, natrum muriaticum, pulsatilla (pratensis), rhus tox, cortisone aceticum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0534
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	ALFALFA	3 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	4 [hp_X] in 1 mL
HORDEUM VULGARE TOP (UNII: 86507VZR9K) (HORDEUM VULGARE TOP - UNII:86507VZR9K)	HORDEUM VULGARE TOP	4 [hp_X] in 1 mL
NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM OFFICINALE - UNII:YH89GMV676)	NASTURTIUM OFFICINALE	4 [hp_X] in 1 mL
RAPHANUS SATIVUS (UNII: 86R5J6D01D) (DAIKON - UNII:86R5J6D01D)	RAPHANUS SATIVUS	4 [hp_X] in 1 mL
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU)	TRITICUM AESTIVUM WHOLE	4 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	6 [hp_X] in 1 mL
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46)	UBIDECARENONE	6 [hp_X] in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	8 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	8 [hp_X] in 1 mL
MANGANESE GLUCONATE (UNII: 9YY2F980SV) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE GLUCONATE	8 [hp_X] in 1 mL
BROWN RICE (UNII: 659G217HPG) (BROWN RICE - UNII:659G217HPG)	BROWN RICE	8 [hp_X] in 1 mL
SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	SUS SCROFA THYROID	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
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 1 mL
ANEMONE PRATENSIS (UNII: 8E272251DI) (ANEMONE PRATENSIS - UNII:8E272251DI)	ANEMONE PRATENSIS	12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 1 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ)	CORTISONE ACETATE	30 [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:43857-0534-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/03/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/03/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0534) , api manufacture(43857-0534) , label(43857-0534) , pack(43857-0534)