FDA.reportPublic FDA data

F08

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 02:25:24

Label at a glance#

ProductF08 FRGV
Active ingredientPINUS SYLVESTRIS FLOWERING TOP, SALIX ALBA FLOWERING TOP, STRYCHNOS IGNATII SEED, VERBASCUM DENSIFLORUM FLOWER, AGASTACHE URTICIFOLIA WHOLE, MIMULUS RINGENS WHOLE, MALUS SYLVESTRIS FLOWER, ARNICA MONTANA, ARNICA MONTANA FLOWER, CEANOTHUS INTEGERRIMUS WHOLE, ILEX AQUIFOLIUM FLOWERING TOP, FAGUS SYLVATICA FLOWERING TOP, EHRENDORFERIA CHRYSANTHA WHOLE
Label structure7 sections

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

Allegheny Monkeyflower Whole

6C 9C 12C

Arnica Montana

9C 12C 15C

Arnica Montana Flower

6C 9C 12C

Crab Apple Flower

6C 9C 12C

Deerbrush Whole

6C 9C 12C

English Holly Flowering Top

6C 9C 12C

European Beech Flowering Top

6C 9C 12C

Golden Eardrops Whole

6C 9C 12C

Ignatia Amara

9C 12C 15C

Mullein Flower

6C 9C 12C

Nettleleaf Giant Hyssop Whole

6C 9C 12C

Pinus Sylvestris Flowering Top

6C 9C 12C

White Willow Flowering Top

6C 9C 12C

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

restlessness*

resentfulness*

anger*

combativeness*

*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, resentfulness, anger, combativeness, 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 Ingredients

INACTIVE INGREDIENT SECTION

alcohol (20% by volume), distilled water

OTC - PURPOSE SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® F08

FLOWER ESSENCES

FRGV™

Homeopathic Formula

Restlessness*

Resentfulness*

1 fl oz (30 mL)

Alcohol 20% by Volume

F0821-0202F0821-0202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0608-1F08FRGV30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0608F08 FRGV (ALLEGHENY MONKEYFLOWER, ARNICA MONTANA, ARNICA MONTANA FLOWER, CEANOTHUS INTEGERRIMUS, EHRENDORFERIA CHRYSANTHA, FAGUS SYLVATICA FLOWER, IGNATIA AMARA, ILEX AQUIFOLIUM FLOWER, MALUS SYLVESTRIS FLOWER, MULLEIN FLOWER, NETTLELEAF GIANT HYSSOP, PINUS SYLVESTRIS FLOWER, SALIX ALBA FLOWER) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bc91d5bd-fa6e-8245-e053-2995a90a3e8c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-060863479-0608-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PINUS SYLVESTRIS FLOWERING TOP2HEM73YI9IACTIB
SALIX ALBA FLOWERING TOPXBP5X7E70RACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
VERBASCUM DENSIFLORUM FLOWERN7FC535Q3RACTIB
AGASTACHE URTICIFOLIA WHOLE8A94843BM7ACTIB
MIMULUS RINGENS WHOLEW4KH5N2DCKACTIB
MALUS SYLVESTRIS FLOWER6ZJ8N1924ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
CEANOTHUS INTEGERRIMUS WHOLEN76K76PTFUACTIB
ILEX AQUIFOLIUM FLOWERING TOP5ENR9SAN1WACTIB
FAGUS SYLVATICA FLOWERING TOP21AF0IHY5UACTIB
EHRENDORFERIA CHRYSANTHA WHOLE68HKD4QMJRACTIB

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
F08 FRGVALLEGHENY MONKEYFLOWER, ARNICA MONTANA, ARNICA MONTANA FLOWER, CEANOTHUS INTEGERRIMUS, EHRENDORFERIA CHRYSANTHA, FAGUS SYLVATICA FLOWER, IGNATIA AMARA, ILEX AQUIFOLIUM FLOWER, MALUS SYLVESTRIS FLOWER, MULLEIN FLOWER, NETTLELEAF GIANT HYSSOP, PINUS SYLVESTRIS FLOWER, SALIX ALBA FLOWERApex Energetics Inc.bc91d5bd-fa6e-8245-e053-2995a90a3e8c2024-01-08WarningsExact identifier
ndc (package): 63479-0608-1
ndc (product): 63479-0608
ndc11 (package): 63479060801
spl id: 0e76f50e-2564-d499-e063-6394a90aa92e
spl set id: bc91d5bd-fa6e-8245-e053-2995a90a3e8c

Reported adverse events (FAERS/openFDA)#

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