Supreme
Supreme is an FDA drug label for the active ingredient 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 manufactured by BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20200911.
- Generic name
- 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
- Manufacturer
- BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 71953-0001
- Application
- N/A
- Label effective
- 20200911
About this product
Supreme is an FDA-registered drug product whose active ingredient is 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. It is labelled by BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71953-0001, label effective 20200911. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing 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 are most often described in connection with: indications helps, improve diencephalic, banking fat. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
INDICATIONS: Helps improve diencephalic banking of fat for consumption by the body.
Dosage & Administration
DIRECTIONS: 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.
Warnings
WARNINGS: 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.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0641-2025 | Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757. | GRACE & FIRE PTY LTD | Class II | Ongoing | 20250917 |
| D-1414-2022 | GUARDIAN ANTACID EX STRGTH TBLT FRT 96CT SKU 901379 GUARDIAN CHWABLE SMTHIES BRRY FSION 60CT SKU 999845 GS EFFERVESCENT ANTACID TABLET 36 CT SKU 913102 GUARDIAN ANTCD TBLT XTRA STGTH BRY 96 CT SKU 914109 GUARDIAN ANTCID TBLT REG STTH FRT 150 CT SKU 914726 GC ANTACID SUPREME CHERRY 12 FL OZ SKU 914112 GUARDIAN ANTD ULTR STRGTH 1000 FRT 72 CT SKU 902322 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | Family Dollar Stores, Llc. | Class II | Ongoing | 20220831 |
| D-0383-2021 | Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ | Hyobin LLC | Class II | Ongoing | 20210526 |
| D-0354-2021 | Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4 | Na Na Collection | Class II | Ongoing | 20210505 |
| D-0572-2017 | SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arbutin otc 2%, Azeliac acid 2%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676 | Synergy Rx | Class II | Terminated | 20170322 |
Frequently asked questions
What is Supreme used for?
INDICATIONS: Helps improve diencephalic banking of fat for consumption by the body.
Who makes Supreme?
BOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE is the labeler of record for Supreme.
What form does Supreme come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Supreme prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Supreme been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.