Aquavit


Uriel Pharmacy Inc.
Human Otc Drug
NDC 48951-1347
Aquavit is a human otc drug labeled by 'Uriel Pharmacy Inc.'. National Drug Code (NDC) number for Aquavit is 48951-1347. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Aquavit drug includes Ambergris - 11 [hp_X]/mL Angelica Archangelica Root - 2 [hp_X]/mL Anise - 2 [hp_X]/mL Black Pepper - 2 [hp_X]/mL Calendula Officinalis Flowering Top - 2 [hp_X]/mL Caraway Seed - 2 [hp_X]/mL Cardamom - 2 [hp_X]/mL Centaurium Erythraea Flowering Top - 2 [hp_X]/mL Chamomile - 2 [hp_X]/mL Cinnamon - 2 [hp_X]/mL and more. The currest status of Aquavit drug is Active.

Drug Information:

Drug NDC: 48951-1347
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: Aquavit
Also known as the trade name. It is the name of the product chosen by the labeler.
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: Aquavit
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Uriel Pharmacy Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Liquid
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:AMBERGRIS - 11 [hp_X]/mL
ANGELICA ARCHANGELICA ROOT - 2 [hp_X]/mL
ANISE - 2 [hp_X]/mL
BLACK PEPPER - 2 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL
CARAWAY SEED - 2 [hp_X]/mL
CARDAMOM - 2 [hp_X]/mL
CENTAURIUM ERYTHRAEA FLOWERING TOP - 2 [hp_X]/mL
CHAMOMILE - 2 [hp_X]/mL
CINNAMON - 2 [hp_X]/mL
COLA NITIDA SEED - 2 [hp_X]/mL
CORIANDER OIL - 2 [hp_X]/mL
EQUISETUM ARVENSE TOP - 2 [hp_X]/mL
FENNEL SEED - 2 [hp_X]/mL
FERRIC OXIDE RED - 9 [hp_X]/mL
FERROUS ARSENATE - 6 [hp_X]/mL
FUMARIA OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL
GINGER - 2 [hp_X]/mL
GOLD - 10 [hp_X]/mL
HONEY - 2 [hp_X]/mL
HYSSOPUS OFFICINALIS WHOLE - 2 [hp_X]/mL
IMPERATORIA OSTRUTHIA ROOT - 2 [hp_X]/mL
JUNIPER BERRY - 2 [hp_X]/mL
LAVANDULA ANGUSTIFOLIA FLOWER - 2 [hp_X]/mL
LESSER GALANGAL ROOT - 2 [hp_X]/mL
LITSEA CUBEBA FRUIT - 2 [hp_X]/mL
LONG PEPPER - 2 [hp_X]/mL
MYRISTICA FRAGRANS WHOLE - 2 [hp_X]/mL
NUTMEG - 2 [hp_X]/mL
OREGANO - 2 [hp_X]/mL
PRUNUS SPINOSA FLOWER BUD - 9 [hp_X]/mL
QUILLAJA SAPONARIA BARK - 2 [hp_X]/mL
ROSMARINUS OFFICINALIS FLOWERING TOP - 2 [hp_X]/mL
SAFFRON - 2 [hp_X]/mL
SEDUM ROSEUM WHOLE - 2 [hp_X]/mL
ST. JOHN'S WORT - 2 [hp_X]/mL
SWEET MARJORAM - 2 [hp_X]/mL
SYZYGIUM AROMATICUM FRUIT - 2 [hp_X]/mL
TANGERINE - 2 [hp_X]/mL
THYME - 2 [hp_X]/mL
VANILLA BEAN - 2 [hp_X]/mL
WHITE PEPPER - 2 [hp_X]/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 01 Sep, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 23 Dec, 2025
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:Uriel Pharmacy 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.
NUI:N0000185375
N0000185371
N0000175629
N0000184306
M0000728
M0006342
M0016962
M0008672
M0022575
M0516536
N0000185508
N0000185015
N0000185001
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:XTC0D02P6C
DTN01M69SN
21C2F5E8RE
KM66971LVF
18E7415PXQ
W2FH8O2BBE
8BC4CUT4JL
ZL25KMM82T
FGL3685T2X
5S29HWU6QB
PQM9SA369U
7626GC95E5
1DP6Y6B65Z
G3QC02NIE6
1K09F3G675
129CO35H12
VH659J61ZL
C5529G5JPQ
79Y1949PYO
Y9H1V576FH
0IQW001KPE
G0NV8P17X0
O84B5194RL
19AH1RAF4M
42LD90786Y
R3617MQA5Z
2NMG4EA7B1
MF7T8BM40A
AEE24M3MQ9
0E5AT8T16U
53Y84VPS2W
8N0K3807ZW
8JM482TI79
E849G4X5YJ
RH0WP583U3
UFH8805FKA
G9Z40ZYU6P
0P6ERS26LL
KH3E3096OO
CW657OBU4N
Q74T35078H
M29DW54Q9E
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.
Pharmacologic Class EPC:Non-Standardized Plant Allergenic Extract [EPC]
Non-Standardized Food Allergenic Extract [EPC]
Standardized Chemical Allergen [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Allergens [CS]
Dietary Proteins [CS]
Plant Proteins [CS]
Food Additives [CS]
Vegetable Proteins [CS]
Seed Storage Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Food Additives [CS]
Fruit Proteins [EXT]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
Seed Storage Proteins [CS]
Standardized Chemical Allergen [EPC]
Vegetable Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
48951-1347-360 mL in 1 BOTTLE, DROPPER (48951-1347-3)01 Sep, 2009N/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: temporary relief of symptoms such as exhaustion, dizziness, nausea, weakness during convalescence and lack of appetite.

Product Elements:

Aquavit aquavit cardamom cardamom lesser galangal root lesser galangal root juniper berry juniper berry lavandula angustifolia flower lavandula angustifolia flower litsea cubeba fruit litsea cubeba fruit fumaria officinalis flowering top fumaria officinalis flowering top black pepper black pepper ferric oxide red ferric oxide red prunus spinosa flower bud prunus spinosa flower bud hyssopus officinalis whole hyssopus officinalis whole syzygium aromaticum fruit syzygium aromaticum fruit ginger ginger oregano oregano glycerin sucrose imperatoria ostruthia root imperatoria ostruthia root sedum roseum whole sedum roseum whole vanilla bean vanilla bean myristica fragrans whole myristica fragrans whole quillaja saponaria bark quillaja saponaria bark cinnamon cinnamon coriander oil coriander oil white pepper white pepper ferrous arsenate ferrous arsenate ambergris ambergris water anise anise centaurium erythraea flowering top centaurium erythraea flowering top angelica archangelica root angelica archangelica root rosmarinus officinalis flowering top rosmarinus officinalis flowering top calendula officinalis flowering top calendula officinalis flowering top equisetum arvense top equisetum arvense top st. john's wort st. john's wort gold gold honey honey chamomile chamomile tangerine tangerine fennel seed fennel seed thyme thyme saffron saffron nutmeg nutmeg long pepper long pepper sweet marjoram sweet marjoram caraway seed caraway seed cola nitida seed cola nitida seed

Indications and Usage:

Directions: for oral use only.

Warnings:

Warnings: claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. do not use if allergic to any ingredient. consult a doctor before use for serious conditions or if conditions worsen or persist. if pregnant or nursing, consult a doctor before use. do not use if safety seal is broken or missing.

Dosage and Administration:

Take 10 drops every hour, in acute situations, decreasing to 4 times daily. ages 12 and older: 10 drops. ages 2-11: 5 drops. under age 2: consult a doctor.

Package Label Principal Display Panel:

Aquavit

Further Questions:

Questions? call 866.642.2858 made with care by uriel, east troy, wi 53120 www.urielpharmacy.com lot#


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.