S01 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


Apex Energetics Inc.
Human Otc Drug
NDC 63479-1901
S01 Allerdrain also known as 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 is a human otc drug labeled by 'Apex Energetics Inc.'. National Drug Code (NDC) number for S01 Allerdrain is 63479-1901. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in S01 Allerdrain drug includes Aloe - 3 [hp_X]/mL Berberis Vulgaris Root Bark - 1 [hp_X]/mL Betula Pendula Leaf - 2 [hp_X]/mL Bryonia Alba Root - 1 [hp_X]/mL Echinacea Angustifolia - 2 [hp_X]/mL Frangula Purshiana Bark - 1 [hp_X]/mL Ginkgo - 2 [hp_X]/mL Histamine Dihydrochloride - 200 [hp_X]/mL Juniperus Communis Stem - 2 [hp_X]/mL Lycopodium Clavatum Spore - 4 [hp_X]/mL and more. The currest status of S01 Allerdrain drug is Active.

Drug Information:

Drug NDC: 63479-1901
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: S01 Allerdrain
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: S01
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: ALLERDRAIN
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: 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
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Apex Energetics Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ALOE - 3 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK - 1 [hp_X]/mL
BETULA PENDULA LEAF - 2 [hp_X]/mL
BRYONIA ALBA ROOT - 1 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA - 2 [hp_X]/mL
FRANGULA PURSHIANA BARK - 1 [hp_X]/mL
GINKGO - 2 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE - 200 [hp_X]/mL
JUNIPERUS COMMUNIS STEM - 2 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE - 4 [hp_X]/mL
MILK THISTLE - 2 [hp_X]/mL
QUERCUS ROBUR FLOWER BUD - 2 [hp_X]/mL
RIBES NIGRUM FLOWER BUD - 2 [hp_X]/mL
ROSA CANINA LEAF - 2 [hp_X]/mL
ROSMARINUS OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL
SCROPHULARIA NODOSA - 2 [hp_X]/mL
SENNA LEAF - 2 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP - 1 [hp_X]/mL
TARAXACUM OFFICINALE - 2 [hp_X]/mL
TEA TREE OIL - 12 [hp_X]/mL
VACCINIUM VITIS-IDAEA LEAF - 2 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:SUBLINGUAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 15 Mar, 1993
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 13 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Apex Energetics Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0818960012076
UPC stands for Universal Product Code.
UNII:V5VD430YW9
1TH8Q20J0U
5HW39H9KDH
T7J046YI2B
VB06AV5US8
4VBP01X99F
19FUJ2C58T
3POA0Q644U
HBU87MH6OY
C88X29Y479
U946SH95EE
VC5I578BE3
VYH9Y9BCCP
J3N2Z889QP
8JM482TI79
7H443NUB2T
AK7JF626KX
5405K23S50
39981FM375
VIF565UC2G
FO2ACM0RMQ
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
63479-1901-130 mL in 1 BOTTLE, GLASS (63479-1901-1)15 Mar, 1993N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Uses: 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.

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

Product Elements:

S01 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 lycopodium clavatum spore lycopodium clavatum spore frangula purshiana bark frangula purshiana bark quercus robur flower bud quercus robur flower bud ribes nigrum flower bud ribes nigrum flower bud rosa canina leaf rosa canina leaf scrophularia nodosa scrophularia nodosa milk thistle milk thistle ginkgo ginkgo histamine dihydrochloride histamine tea tree oil tea tree oil rosmarinus officinalis flowering top rosmarinus officinalis flowering top water berberis vulgaris root bark berberis vulgaris root bark betula pendula leaf betula pendula leaf bryonia alba root bryonia alba root aloe aloe juniperus communis stem juniperus communis stem vaccinium vitis-idaea leaf vaccinium vitis-idaea leaf echinacea angustifolia echinacea angustifolia taraxacum officinale taraxacum officinale senna leaf senna leaf solidago virgaurea flowering top solidago virgaurea flowering top alcohol

Indications and Usage:

Uses: 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: if pregnant or breastfeeding , ask a health professional before use. do not use if clear seal over the cap is broken or missing. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. 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.

Dosage and Administration:

Directions: 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.

Stop Use:

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.

Package Label Principal Display Panel:

Futureplex® s01 allertox® allerdrain™ homeopathic formula congestion* rashes* digestive discomfort* 1 fl oz (30 ml) alcohol 20% by volume s0121-0129

Further Questions:

Distributed by apex energetics. questions? 16592 hale ave., irvine, ca 92606, usa


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.