FDA.reportPublic FDA data

Supreme

Manufacturer
BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE | Apotheca Company
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:18

Label at a glance#

ProductSupreme
Active ingredientARTEMISIA ABROTANUM FLOWERING TOP, ANACARDIUM OCCIDENTALE FRUIT, ARSENIC TRIOXIDE, BARIUM CHLORIDE DIHYDRATE, HELLEBORUS NIGER ROOT, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, NIACINAMIDE, CLAVICEPS PURPUREA SCLEROTIUM, BOS TAURUS THYMUS, THYROID, BOVINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, SUS SCROFA HYPOTHALAMUS, BOS TAURUS PITUITARY GLAND, POSTERIOR, SILICON DIOXIDE
Label structure9 sections

Dosage and administration

Swirl or shake bottle ten times prior to each use. Apply 3 sprays under tongue twice per day, before bedtime and upon awakening. Do not eat, drink or brush teeth within 15 minutes before or after taking this product. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Abrotanum 6X, 12X, 30C, Anacardium Orientale 6X, 12X, 30C, Arsenicum Album 6X, 12X, 30C, Baryta Muriatica 6X, 12X, 30C, Helleborus Niger 6X, 12X, 30C, Ignatia Amara 6X, 12X, 30C, Lycopodium Clavatum 6X, 12X, 30C, Nicotinamidum 6X, 12X, 30C, Secale Cornutum 6X, 12X, 30C, Thymus (Bovine) 6X, 12X, 30C, Thyroidinum (Bovine) 6X, 12X, 30C, Calcarea Carbonica 8X, 12X, 30C, Calcarea Phosphorica 8X, 12X, 30C, Hypothalamus Suis 8X, 12X, 30C, Pituitarum Posterium (Bovine) 8X, 12X, 30C, Silicea 8X, 12X, 30C.

INDICATIONS:

OTC - PURPOSE SECTION

Helps improve diencephalic banking of fat for consumption by the body.

WARNINGS:

WARNINGS SECTION

Do not use if seal is damaged or missing.

Refrain from use if pregnant or lactating.

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

OTHER INFORMATION:

Store in a cool, dry place. Tamper resistant for your protection. Use only if safety seal is intact.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Swirl or shake bottle ten times prior to each use. Apply 3 sprays under tongue twice per day, before bedtime and upon awakening. Do not eat, drink or brush teeth within 15 minutes before or after taking this product. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Helps improve diencephalic banking of fat for consumption by the body.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, Organic Ethanol 20%, Glycerin.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

The Weight Loss Company

19495 Biscayne Blvd.

Miami, FL 33180

sozaweightloss.us

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71953-0001-1

soza

weightloss

so simple. so different.

SUPREME

WEIGHT + APPETITE SUPPORT

For PROFESSIONAL Use Only

1 FL. OZ. (30 ml)

HOMEOPATHIC FORMULA

SupremeSupreme

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71953-0001-1Supreme30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71953-0001SUPREME (ABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEA) LIQUID [BOUARI GROUP, LLC DBA WEIGHT LOSS COMPANY, THE]2Current NDC, Legacy NDC, 1 package rows20200915_72c4679b-aa97-4888-9178-581d0f99c0b6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71953-000171953-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARTEMISIA ABROTANUM FLOWERING TOPQG07G580U0ACTIB
ANACARDIUM OCCIDENTALE FRUIT4A10JR4E7EACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BARIUM CHLORIDE DIHYDRATEEL5GJ3U77EACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
NIACINAMIDE25X51I8RD4ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
BOS TAURUS THYMUS8XEJ88V2T8ACTIB
THYROID, BOVINEMN18OTN73WACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
SUS SCROFA HYPOTHALAMUSN6R0856Z79ACTIB
BOS TAURUS PITUITARY GLAND, POSTERIOR7JM57I419KACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SupremeABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEABOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE72c4679b-aa97-4888-9178-581d0f99c0b62020-09-11WarningsExact identifier
ndc (package): 71953-0001-1
ndc (product): 71953-0001
ndc11 (package): 71953000101
spl id: e793581d-f746-4253-b9be-59994c75f955
spl set id: 72c4679b-aa97-4888-9178-581d0f99c0b6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.