ADRENAL TONIC- aralia quinquefolia, glycyrrhiza glabra, sarsaparilla, avena sativa, glandula suprarenalis bovine, adrenalinum, arsenicum album, kali phosphoricum, natrum muriaticum, nux vomica, phosphoricum acidum, veratrum album 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:

Aralia Quinquefolia 1X, Glycyrrhiza Glabra 1X, Sarsaparilla 1X, 12X, Avena Sativa 3X, Glandula Suprarenalis Bovine 8X, Adrenalinum 12X, 30X, Arsenicum Album 12X, Kali Phosphoricum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Veratrum Album 12X.

INDICATIONS:

For temporary relief of marked debility producing nervous exhaustion, weakness and exhaustion following acute illness; and rheumatic pains in the sacrum and joints with muscular weakness.

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 cool, dry place.

DIRECTIONS:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

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.

INDICATIONS:

For temporary relief of marked debility producing nervous exhaustion, weakness and exhaustion following acute illness; and rheumatic pains in the sacrum and joints with muscular weakness.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

ADRENAL TONIC

HOMEOPATHIC

1 FL OZ (30 ml)

Adrenal Tonic

ADRENAL TONIC
aralia quinquefolia, glycyrrhiza glabra, sarsaparilla, avena sativa, glandula suprarenalis bovine, adrenalinum, arsenicum album, kali phosphoricum, natrum muriaticum, nux vomica, phosphoricum acidum, veratrum album liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0057
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	1 [hp_X] in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	1 [hp_X] in 1 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SMILAX ORNATA ROOT - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	1 [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
BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29)	BOS TAURUS ADRENAL GLAND	8 [hp_X] in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	12 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	12 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	12 [hp_X] in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	12 [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:43857-0057-1	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/23/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/23/2016

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0057) , api manufacture(43857-0057) , label(43857-0057) , pack(43857-0057)