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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0057
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG1 [hp_X]  in 1 mL
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA1 [hp_X]  in 1 mL
SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT1 [hp_X]  in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 1 mL
BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND8 [hp_X]  in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0057-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/23/2016
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0057) , api manufacture(43857-0057) , label(43857-0057) , pack(43857-0057)

Revised: 5/2016
Document Id: efc2a916-32ab-4e1b-8575-131f6c9ea685
Set id: 2bbf65e2-47b9-46d3-a8de-69bc543783f8
Version: 2
Effective Time: 20160523
 
BioActive Nutritional, Inc.