FDA.reportPublic FDA data

S01

Manufacturer
Apex Energetics Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:21

Label at a glance#

ProductS01 ALLERDRAIN
Active ingredientLYCOPODIUM CLAVATUM SPORE, FRANGULA PURSHIANA BARK, QUERCUS ROBUR FLOWER BUD, RIBES NIGRUM FLOWER BUD, ROSA CANINA LEAF, SCROPHULARIA NODOSA, MILK THISTLE, GINKGO, HISTAMINE DIHYDROCHLORIDE, TEA TREE OIL, ROSMARINUS OFFICINALIS FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, BETULA PENDULA LEAF, BRYONIA ALBA ROOT, ALOE, JUNIPERUS COMMUNIS STEM, VACCINIUM VITIS-IDAEA LEAF, ECHINACEA ANGUSTIFOLIA, TARAXACUM OFFICINALE, SENNA LEAF, SOLIDAGO VIRGAUREA FLOWERING TOP
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

Aloe Socotrina

3X

Berberis Vulgaris

1X

Betula Verrucosa Leaf

2X

Bryonia

1X

Carduus Marianus

2X

Echinacea Angustifolia

2X

Ginkgo Biloba

2X

Histaminum Hydrochloricum

6X 12X 30X 200X

Juniperus Communis Stem

2X

Lycopodium Clavatum

4X

Melaleuca Alternifolia Oil

4X 8X 10X 12X

Quercus Robur Flower Bud

2X

Rhamnus Purshiana

1X

Ribes Nigrum Flower Bud

2X

Rosa Canina Leaf

2X

Rosmarinus Officinalis

2X

Scrophularia Nodosa

2X

Senna

2X

Solidago Virgaurea

1X

Taraxacum Officinale

2X

Vaccinium Vitus-Idaea Leaf

2X

INDICATIONS & USAGE SECTION

Uses:

OTC - PURPOSE SECTION

For temporary relief of minor:

congestion*

rashes*

digestive discomfort*

tiredness*

flatulence*

acne*

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

Warnings:

WARNINGS SECTION

OTC - PURPOSE 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 congestion, rashes, digestive discomfort, tiredness, flatulence, acne, 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 - QUESTIONS SECTION

Distributed by Apex Energetics. Questions?

16592 Hale Ave., Irvine, CA 92606, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUTUREPLEX® S01

ALLERTOX®

ALLERDRAIN™

Homeopathic Formula

Congestion*

Rashes*

Digestive Discomfort*

1 fl oz (30 mL)

Alcohol 20% by Volume

S0121-0129S0121-0129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63479-1901-1S01ALLERDRAIN30 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63479-1901S01 ALLERDRAIN (ALOE SOCOTRINA, BERBERIS VULGARIS, BETULA VERRUCOSA, BRYONIA, CARDUUS MARIANUS, ECHINACEA ANGUSTIFOLIA, GINKGO BILOBA, HISTAMINUM HYDROCHLORICUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MELALEUCA ALTERNIFOLIA OIL, QUERCUS ROBUR, RHAMNUS PURSHIANA, RIBES NIGRUM, ROSA CANINA, ROSMARINUS OFFICINALIS, SCROPHULARIA NODOSA, SENNA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, VACCINIUM VITUS IDAEA) SOLUTION/ DROPS [APEX ENERGETICS INC.]3Current NDC, Legacy NDC, 1 package rows20240110_b9d2a7ef-28bd-4882-e053-2a95a90a0fdd.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63479-190163479-1901-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
FRANGULA PURSHIANA BARK4VBP01X99FACTIB
QUERCUS ROBUR FLOWER BUDVC5I578BE3ACTIB
RIBES NIGRUM FLOWER BUDVYH9Y9BCCPACTIB
ROSA CANINA LEAFJ3N2Z889QPACTIB
SCROPHULARIA NODOSA7H443NUB2TACTIB
MILK THISTLEU946SH95EEACTIB
GINKGO19FUJ2C58TACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
TEA TREE OILVIF565UC2GACTIB
ROSMARINUS OFFICINALIS FLOWERING TOP8JM482TI79ACTIB
WATER059QF0KO0RIACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BETULA PENDULA LEAF5HW39H9KDHACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ALOEV5VD430YW9ACTIB
JUNIPERUS COMMUNIS STEMHBU87MH6OYACTIB
VACCINIUM VITIS-IDAEA LEAFFO2ACM0RMQACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
SENNA LEAFAK7JF626KXACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
ALCOHOL3K9958V90MIACT

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
S01 ALLERDRAINALOE SOCOTRINA, BERBERIS VULGARIS, BETULA VERRUCOSA, BRYONIA, CARDUUS MARIANUS, ECHINACEA ANGUSTIFOLIA, GINKGO BILOBA, HISTAMINUM HYDROCHLORICUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MELALEUCA ALTERNIFOLIA OIL, QUERCUS ROBUR, RHAMNUS PURSHIANA, RIBES NIGRUM, ROSA CANINA, ROSMARINUS OFFICINALIS, SCROPHULARIA NODOSA, SENNA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, VACCINIUM VITUS IDAEAApex Energetics Inc.b9d2a7ef-28bd-4882-e053-2a95a90a0fdd2024-01-08WarningsExact identifier
ndc (package): 63479-1901-1
ndc (product): 63479-1901
ndc11 (package): 63479190101
spl id: 0e775a95-3ba3-f934-e063-6394a90a314f
spl set id: b9d2a7ef-28bd-4882-e053-2a95a90a0fdd

Reported adverse events (FAERS/openFDA)#

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