NDC | 61300-0001-1 |
Set ID | 03342549-66a9-4002-8b9c-fefef01a326a |
Category | HUMAN OTC DRUG LABEL |
Packager | Arize Supplements, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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:
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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:
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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:
- QUESTIONS:
- PACKAGE LABEL DISPLAY
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INGREDIENTS AND APPEARANCE
MAX
abrotanum (artemisia abrotanum), anacardium orientale, baryta muriatica, calcarea carbonica, calcarea phosphorica, fucus vesiculosus, graphites, helleborus niger, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61300-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61300-0001-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/30/2014 07/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/30/2014 07/11/2023 Labeler - Arize Supplements, LLC (079201010) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(61300-0001) , api manufacture(61300-0001) , label(61300-0001) , pack(61300-0001)