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NDC 61300-0001-01 MAX 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [h Details

MAX 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [h

MAX is a ORAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Arize Supplements, LLC. The primary component is ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELATONIN; NIACINAMIDE; ONION; OYSTER SHEL.

Product Information

NDC	61300-0001
Product ID	61300-0001_388b5efd-9bb1-40d2-89b0-7ad1ff5b923e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	MAX
Proprietary Name Suffix	n/a
Non-Proprietary Name	Abrotanum (Artemisia abrotanum), Anacardium orientale, Baryta muriatica, Calcarea carbonica, Calcarea phosphorica, Fucus vesiculosus, Graphites, Helleborus niger,
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	ORAL
Active Ingredient Strength	8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [h
Substance Name	ARTEMISIA ABROTANUM FLOWERING TOP; BARIUM CHLORIDE DIHYDRATE; CLAVICEPS PURPUREA SCLEROTIUM; FUCUS VESICULOSUS; GRAPHITE; HELLEBORUS NIGER ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MELATONIN; NIACINAMIDE; ONION; OYSTER SHEL
Labeler Name	Arize Supplements, LLC
Pharmaceutical Class	Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increa
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 61300-0001-01 (61300000101)

Pricing Information	N/A
NDC Package Code	61300-0001-1
Billing NDC	61300000101
Package	30 mL in 1 BOTTLE, SPRAY (61300-0001-1)
Marketing Start Date	2014-04-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 03342549-66a9-4002-8b9c-fefef01a326a Details

ACTIVE INGREDIENTS:

Abrotanum (Aremisia abrotanum) 8X, Anacardium orientale 8X, Baryta muriatica 8X, Calcarea carbonica 8X, Calcarea phosphorica 8X, Fucus vesiculosus 8X, Graphites 8X, Helleborus niger 8X, Hypothalamus (suis) 8X, Ignatia amara 8X, Lycopodium clavatum 8X, Magnesia phosphorica 8X, Secale cornutum 8X, Silicea 8X, Thymolum 8X, Thyroidinum (suis) 8X, Allium cepa 8X, 2X, 16X, Hepar suis 8X, 12X, 16X, Pancreas suis 8X, 12X, 16X, Glandula suprarenalis suis 8X, 12X, 16X, Melatonin 8X, 32C, Nicotinamidum 8X, 32C, Oophorinum (suis) 8X, 32C, Orchitinum (suis) 8X, 32C, Serotonin (hydrochloride) 8X, 32C, Thiaminum hydrochloricum 8X, 32C, Solidago virgaurea 12X.

INDICATIONS:

For temporary relief of symptoms related to increased appetite, cravings, regulation of fat metabolism and detoxification stress. May provide glandular support of the liver, gallbladder, endocrine system and neuro-endocrine metabolism.

WARNINGS:

Stop use if conditions persist or worsen.

If pregnant or breast feeding ask a healthcare professional before use.

Keep out of reach of children. Contains Alcohol. In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION: 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. Contains alcohol. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Swirl or shake bottle vigorously 5-10 times prior to use. Apply three sprays under your tongue twice per day, upon awakening and at bedtime. Do not eat, drink or brush your teeth within 5-10 minutes before or after taking this product. Consult your physician prior to use in children under 12 years of age.

INDICATIONS:

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol

QUESTIONS:

Distributed by:

ARIZE Supplements, LLC

400 Whitesport Dr SW, Suite 101, Huntsville, AL 25801

PACKAGE LABEL DISPLAY

NDC 61300-0001-1

ARIZE CLINIC

Maximize Your Weight Health Journey

MAX

WEIGHT LOOS AND APPETITE CONTROL

Proprietary Homeopathic Remedy

For Professional Use Only

20% Ethanol

1 FL. OZ. (30 ml)

INGREDIENTS AND APPEARANCE

MAX

abrotanum (artemisia abrotanum), anacardium orientale, baryta muriatica, calcarea carbonica, calcarea phosphorica, fucus vesiculosus, graphites, helleborus niger, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61300-0001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0)	ARTEMISIA ABROTANUM FLOWERING TOP	8 [hp_X] in 1 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	8 [hp_X] in 1 mL
BARIUM CHLORIDE DIHYDRATE (UNII: EL5GJ3U77E) (BARIUM CATION - UNII:V645272HLN)	BARIUM CHLORIDE DIHYDRATE	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	8 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	8 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	8 [hp_X] in 1 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	8 [hp_X] in 1 mL
HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815)	HELLEBORUS NIGER ROOT	8 [hp_X] in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	8 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	8 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	8 [hp_X] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X] in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	8 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	8 [hp_X] in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	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
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	8 [hp_X] in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	8 [hp_X] in 1 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	8 [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
MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL)	MELATONIN	8 [hp_X] in 1 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	8 [hp_X] in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	8 [hp_X] in 1 mL
SUS SCROFA TESTICLE (UNII: KM02613O28) (SUS SCROFA TESTICLE - UNII:KM02613O28)	SUS SCROFA TESTICLE	8 [hp_X] in 1 mL
SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY)	SEROTONIN HYDROCHLORIDE	8 [hp_X] in 1 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	8 [hp_X] in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	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:61300-0001-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/30/2014	07/11/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/30/2014	07/11/2023

Labeler - Arize Supplements, LLC (079201010)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(61300-0001) , api manufacture(61300-0001) , label(61300-0001) , pack(61300-0001)

Revised: 1/2021

Document Id: 388b5efd-9bb1-40d2-89b0-7ad1ff5b923e

Set id: 03342549-66a9-4002-8b9c-fefef01a326a

Version: 3

Effective Time: 20210122

Search by Drug Name or NDC

Product Information

Package

Package Images

NDC 61300-0001-01 (61300000101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 03342549-66a9-4002-8b9c-fefef01a326a Details

ACTIVE INGREDIENTS:

INDICATIONS:

WARNINGS:

KEEP OUT OF REACH OF CHILDREN:

DIRECTIONS:

INDICATIONS:

INACTIVE INGREDIENTS:

QUESTIONS:

PACKAGE LABEL DISPLAY

INGREDIENTS AND APPEARANCE

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