FDA.reportPublic FDA data

Aquavit

Manufacturer
Uriel Pharmacy Inc.
Effective date
2025-06-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:33:57

Label at a glance#

ProductAquavit
Active ingredientCARDAMOM, LESSER GALANGAL ROOT, JUNIPER BERRY, LAVANDULA ANGUSTIFOLIA FLOWER, LITSEA CUBEBA FRUIT, FUMARIA OFFICINALIS FLOWERING TOP, BLACK PEPPER, FERRIC OXIDE RED, PRUNUS SPINOSA FLOWER BUD, HYSSOPUS OFFICINALIS WHOLE, SYZYGIUM AROMATICUM FRUIT, GINGER, IMPERATORIA OSTRUTHIA ROOT, OREGANO, SEDUM ROSEUM WHOLE, VANILLA BEAN, MYRISTICA FRAGRANS WHOLE, QUILLAJA SAPONARIA BARK, CINNAMON, CORIANDER OIL, WHITE PEPPER, FERROUS ARSENATE, AMBERGRIS, ANISE, CENTAURIUM ERYTHRAEA FLOWERING TOP, ANGELICA ARCHANGELICA ROOT, ROSMARINUS OFFICINALIS FLOWERING TOP, CALENDULA OFFICINALIS FLOWERING TOP, EQUISETUM ARVENSE TOP, ST. JOHN'S WORT, GOLD, HONEY, CHAMOMILE, TANGERINE, FENNEL SEED, THYME, SAFFRON, NUTMEG, LONG PEPPER, SWEET MARJORAM, CARAWAY SEED, COLA NITIDA SEED
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 10 drops every hour with water, 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.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100 gm contains: 75 gm Mel (Honey) 2X; Melissa (Lemon balm) 2X, 50 gm Archangelica (Angelica) 2X, Calendula 2X, Equisetum (Horsetail) 2X, Hypericum (St. John's wort) 2X, Imperatoria (Masterwort) 2X, Rosa (Garden rose) 2X, Rosmarinus (Rosemary) 2X; 25 gm Chamomilla (Chamomile) 2X, Citrus reticulata (Orange) 2X, Elettaria cardamum (Cardamom) 2X, Galangal (Ginger) 2X, Juniperus (Juniper) 2X, Lavender 2X, Marjorana (Marjoram) 2X; Salvia (Sage) 2X, 20 gm Anisum (Anise) 2X, Centurium (Centaury) 2X; 10 gm Carvi (Caraway) 2X, Kola (Cola e sem) 2X, Cubebae (Pepper) 2X, Foeniculum vulgare (Fennel) 2X, Fumaria (Fumitory) 2X, Hyssopus (Hyssop) 2X, Myristica fragrans (Mace) 2X, Piper album (White pepper) 2X, Syzygium aromaticum (Clove) 2X, Thymus vulgaris (Thyme) 2X, Zingiberis (Ginger) 2X; 5 gm China (Peruvian bark) 2X, Cinnamomum cassia (Cinnamon) 2X, Coriandrum sativum (Coriander) 2X, Crocus sativus (Saffron) 2X, Myristica fragrans (Nutmeg) 2X, Origanum vulgare (Oregano) 2X, Piper longum (Long pepper) 2X, Piper nigrum (Black pepper) 2X, Vanilla 2X; Levico (Mineral spring water) 6X, Hematite (Red iron ore) 9X, Prunus spin. cum Ferro (Blackthorn, Iron) 9X, Aurum (Gold) 10X, Ambra grisea (Amber gris) 11x

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Spring water, Glycerin, Organic cane sugar

Prepared using rhythmical processes

OTC - PURPOSE SECTION

Uses: Temporary relief of symptoms such as exhaustion, dizziness, nausea, weakness during convalescence and lack of appetite.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

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.

Refrigerate after opening. Best when used within 30days of opening.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aquavit LiquidAquavit Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1347-3Aquavit60 mL in 1 BOTTLE, DROPPERLIQUID607

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-134748951-1347-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARDAMOM8BC4CUT4JLACTIB
LESSER GALANGAL ROOT42LD90786YACTIB
JUNIPER BERRYO84B5194RLACTIB
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MACTIB
LITSEA CUBEBA FRUITR3617MQA5ZACTIB
FUMARIA OFFICINALIS FLOWERING TOPVH659J61ZLACTIB
BLACK PEPPERKM66971LVFACTIB
FERRIC OXIDE RED1K09F3G675ACTIB
PRUNUS SPINOSA FLOWER BUD53Y84VPS2WACTIB
HYSSOPUS OFFICINALIS WHOLE0IQW001KPEACTIB
SYZYGIUM AROMATICUM FRUIT0P6ERS26LLACTIB
GINGERC5529G5JPQACTIB
IMPERATORIA OSTRUTHIA ROOTG0NV8P17X0ACTIB
OREGANO0E5AT8T16UACTIB
GLYCERINPDC6A3C0OXIACT
SUCROSEC151H8M554IACT
SEDUM ROSEUM WHOLERH0WP583U3ACTIB
VANILLA BEANQ74T35078HACTIB
MYRISTICA FRAGRANS WHOLEMF7T8BM40AACTIB
QUILLAJA SAPONARIA BARK8N0K3807ZWACTIB
CINNAMON5S29HWU6QBACTIB
CORIANDER OIL7626GC95E5ACTIB
WHITE PEPPERM29DW54Q9EACTIB
FERROUS ARSENATE129CO35H12ACTIB
AMBERGRISXTC0D02P6CACTIB
WATER059QF0KO0RIACT
ANISE21C2F5E8REACTIB
CENTAURIUM ERYTHRAEA FLOWERING TOPZL25KMM82TACTIB
ANGELICA ARCHANGELICA ROOTDTN01M69SNACTIB
ROSMARINUS OFFICINALIS FLOWERING TOP8JM482TI79ACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
ST. JOHN'S WORTUFH8805FKAACTIB
GOLD79Y1949PYOACTIB
HONEYY9H1V576FHACTIB
CHAMOMILEFGL3685T2XACTIB
TANGERINEKH3E3096OOACTIB
FENNEL SEEDG3QC02NIE6ACTIB
THYMECW657OBU4NACTIB
SAFFRONE849G4X5YJACTIB

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
AquavitAQUAVITUriel Pharmacy Inc.c1c0887a-c388-c737-e053-2a95a90a076c2025-06-06WarningsExact identifier
ndc (package): 48951-1347-3
ndc (product): 48951-1347
ndc11 (package): 48951134703
spl id: 36eb9714-c682-cbf1-e063-6394a90ac71f
spl set id: c1c0887a-c388-c737-e053-2a95a90a076c

Reported adverse events (FAERS/openFDA)#

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