FDA.reportPublic FDA data

F03

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:25

Label at a glance#

ProductF03 FR-RLS
Active ingredientARSENIC TRIOXIDE, VIOLA ODORATA FLOWER, GELSEMIUM SEMPERVIRENS ROOT, ERIOBOTRYA JAPONICA WHOLE, LUFFA OPERCULATA FRUIT, MIMULUS GUTTATUS FLOWERING TOP, TOXICODENDRON DIVERSILOBUM WHOLE, PENSTEMON DAVIDSONII WHOLE, AESCULUS CARNEA FLOWER, RUBUS URSINUS WHOLE, PRUNUS CERASIFERA FLOWER, ALLIUM SATIVUM WHOLE, POPULUS TREMULA FLOWERING TOP, DIPLACUS AURANTIACUS WHOLE, HELIANTHEMUM NUMMULARIUM FLOWER, WATERMELON, LILIUM LANCIFOLIUM WHOLE FLOWERING
Label structure7 sections

Indications and uses

For temporary relief of minor: restlessness* fearfulness* backache* cold sweat* buzzing ears* weak memory* dizziness* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Arsenicum Album

6C 9C 12C 15C 20C

California Blackberry Whole

6C 9C 12C

Cherry Plum Flower

6C 9C 12C

Common Violet Flower

6C 9C 12C

Cultivated Garlic Whole

6C 9C 12C

European Aspen Flowering Top

6C 9C 12C

Gelsemium Sempervirens

6C 9C 12C 15C 20C

Lilium Tigrinum

6C 9C 12C 15C 20C

Loquat Whole

6C 9C 12C

Luffa Operculata

6C 9C 12C

Mimulus Guttatus Flowering Top

6C 9C 12C

Orange Bush Monkeyflower Whole

6C 9C 12C

Pacific Poisonoak Whole

6C 9C 12C

Penstemon Davidsonii Whole

6C 9C 12C

Red Horse-Chestnut Flower

6C 9C 12C

Rockrose Flower

6C 9C 12C

Watermelon

6C 9C 12C

Uses:

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For temporary relief of minor:

restlessness*

fearfulness*

backache*

cold sweat*

buzzing ears*

weak memory*

dizziness*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTHER SAFETY INFORMATION

Do not use if clear seal over the cap is broken or missing.

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if restlessness, fearfulness, backache, cold sweat, buzzing ears, weak memory, dizziness, or other symptoms do not improve within 7 days or are accompanied by fever.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), distilled water

OTC - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® F03

Flower Essences

FR-RLS™

Homeopathic Formula

Restlessness*

Fearfulness*

1 fl oz (30 mL)

Alcohol 20% by Volume

F0321-0312F0321-0312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0603-1F03FR-RLS30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0603F03 FR-RLS (ASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINE) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bccede22-e48f-52bc-e053-2995a90a6d0f.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-060363479-0603-1

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
ARSENIC TRIOXIDES7V92P67HOACTIB
VIOLA ODORATA FLOWER438W01FC7AACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
ERIOBOTRYA JAPONICA WHOLE2FCJ9QNJ7OACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
MIMULUS GUTTATUS FLOWERING TOP192426I5JUACTIB
TOXICODENDRON DIVERSILOBUM WHOLE9211E5735BACTIB
PENSTEMON DAVIDSONII WHOLE8K9DCX606ZACTIB
AESCULUS CARNEA FLOWER717DPT98VMACTIB
RUBUS URSINUS WHOLEEB3AN7DKSLACTIB
PRUNUS CERASIFERA FLOWER0KD7R09EASACTIB
ALLIUM SATIVUM WHOLEIIF21WT8O3ACTIB
POPULUS TREMULA FLOWERING TOP5Q01F7TPJJACTIB
DIPLACUS AURANTIACUS WHOLETO6G4140YAACTIB
HELIANTHEMUM NUMMULARIUM FLOWER51BRR32WPPACTIB
WATERMELON231473QB6RACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB

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
F03 FR-RLSASPEN, ARSENICUM ALBUM, DIPLACUS AURANTIACUS, GARLIC, LILIUM TIGRINUM, LOQUAT, LUFFA OPERCULATA, MIMULUS GUTTATUS, PENSTEMON DAVIDSONII, PRUNUS CERASIFERA, RED HORSE CHESTNUT, RUBUS URSINUS, ROCKROSE, TOXICODENDRON DIVERSILOBUM, VIOLA ODORATA, WATERMELON, YELLOW JASMINEApex Energetics Inc.bccede22-e48f-52bc-e053-2995a90a6d0f2024-01-08WarningsExact identifier
ndc (package): 63479-0603-1
ndc (product): 63479-0603
ndc11 (package): 63479060301
spl id: 0e76e634-d944-70ac-e063-6294a90a6ad3
spl set id: bccede22-e48f-52bc-e053-2995a90a6d0f

Reported adverse events (FAERS/openFDA)#

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