E08

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 02:25:30

Label at a glance#

ProductE08 BIOCLOCK REGULATOR
Active ingredientCARPINUS BETULUS FLOWER, OLEA EUROPAEA FLOWER, GELSEMIUM SEMPERVIRENS ROOT, ANAMIRTA COCCULUS SEED, BOS TAURUS HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, PHOSPHORIC ACID, LACTIC ACID, L-, SEPIA OFFICINALIS JUICE, POTASSIUM CARBONATE, POTASSIUM PHOSPHATE, DIBASIC, TYROSINE, SOLIDAGO VIRGAUREA FLOWERING TOP, ORNITHOGALUM UMBELLATUM FLOWERING TOP, FRANGULA PURSHIANA BARK, PASSIFLORA INCARNATA TOP, SUS SCROFA PINEAL GLAND, BETULA PENDULA LEAF, CALCIUM IODIDE, CANIS LUPUS FAMILIARIS MILK, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, RIBES NIGRUM FLOWER BUD, TRYPTOPHAN, ELEUTHERO, STRYCHNOS NUX-VOMICA SEED, COLCHICUM AUTUMNALE BULB
Label structure7 sections

Dosage and administration

Adults & children ages 12 years and over: Take 10 drops under the tongue in the morning and evening, 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

Betula Verrucosa Leaf

3X 6X

Bos Taurus Adrenal Gland

4C

Bos Taurus Pituitarum Posterium

7C

Calcarea Iodata

8X 12X

Cocculus Indicus

6X 9X 12X

Colchicum Autumnale

6X 9X 12X

Eleuthero

3X 6X 9X

European Hornbeam Flower

12X 30X

European Olive Flower

12X 30X

Gelsemium Sempervirens

9X 12X 15X

Hypothalamus

7C

Juniperus Communis Stem

3X 6X 9X

Kali Carbonicum

6X 9X 12X

Kali Phosphoricum

4X 6X 9X 12X 30X

Lac Caninum

10X 12X 15X

Nux Vomica

6X 9X 12X 15X 30X

Passiflora Incarnata

2X 4X 6X 12X

Phosphoricum Acidum

4X 6X 9X 12X

Pyrenees Star Of Bethlehem Flowering Top

12X 30X

Rhamnus Purshiana

2X 4X 6X

Ribes Nigrum Flower Bud

2X 4X 8X

Sarcolacticum Acidum

3X 6X 9X 12X 30X

Sepia

6X 9X 12X 15X 30X

Solidago Virgaurea

3X 6X 9X

Sus Scrofa Pineal Gland

4C

Tryptophan

7C

Tyrosine

7C

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

sleep disturbances*

headache*

fatigue*

menstrual irregularity*

lightheadedness*

yawning*

*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 sleep disturbances, headache, fatigue, menstrual irregularity, lightheadedness, yawning, 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 in the morning and evening, 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 - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?1

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® E08

ANTITOX®

BIOCLOCK REGULATOR™

Homeopathic Formula

Sleep Disturbances*

Headache* Fatigue*

1 fl oz (30 mL)

Alcohol 20% by Volume

E08 Bioclock Regulator 20210317 label.jpgE08 Bioclock Regulator 20210317 label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-0508-1E08BIOCLOCK REGULATOR30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-0508E08 BIOCLOCK REGULATOR (BETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINE) SOLUTION/ DROPS [APEX ENERGETICS INC.]2Current NDC, Legacy NDC, 1 package rows20240110_bf77d8e4-cf1c-447f-e053-2995a90a8c6f.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-050863479-0508-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
E08 BIOCLOCK REGULATORBETULA VERRUCOSA, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARUM POSTERIUM, CALCAREA IODATA, COCCULUS INDICUS, COLCHICUM AUTUMNALE, ELEUTHERO, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE, HYPOTHALAMUS, JUNIPERUS COMMUNIS STEM, KALI CARBONICUM, KALI PHOSPHORICUM, LAC CANINUM, NUX VOMICA, PASSIFLORA INCARNATA, ORNITHOGALUM UMBELLATUM, PHOSPHORICUM ACIDUM, RHAMNUS PURSHIANA, RIBES NIGRUM, SARCOLACTICUM ACIDUM, SEPIA, SOLIDAGO VIRGAUREA, SUS SCROFA PINEAL GLAND, TRYPTOPHAN, TYROSINE, YELLOW JASMINEApex Energetics Inc.bf77d8e4-cf1c-447f-e053-2995a90a8c6f2024-01-08WarningsExact identifier
ndc (package): 63479-0508-1
ndc (product): 63479-0508
ndc11 (package): 63479050801
spl id: 0e76f0d9-0ac3-e097-e063-6394a90adba2
spl set id: bf77d8e4-cf1c-447f-e053-2995a90a8c6f

Reported adverse events (FAERS/openFDA)#

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