Aquavit 1 Liquid
FDA Label NDC 48951-1065

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Aquavit 1 (NDC 48951-1065). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications & Usage

Directions: FOR ORAL USE.

Dosage & Administration

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

Otc - Active Ingredient

Active Ingredients: 100 gm contains: 75 gm Mel (Honey) 4X; 50 gm Archangelica (Longwort) 4X, Calendula 4X, Equisetum (Common horsetail) 4X, Hypericum (St. John’s Wort) 4X, Imperatoria (Masterwort) 4X, Rosa (Garden rose) 4X, Rosmarinus (Rosemary) 4X; 25 gm Chamomilla (Chamomile) 4X, Citrus reticulata (Mandarin orange) 4X, Elettaria cardamum (True cardamom) 4X, Galangal (Ginger) 4X, Juniperus (Common juniper) 4X, Lavender 4X, Marjorana (Marjoram) 4X; 20 gm Anisum (Anise) 4X, Centurium (Centaury) 4X; 10 gm Carvi (Caraway) 4X, Cola (Cola nut) 4X, Cubebae (Cubeb) 4X, Foeniculum vulgare (Fennel) 4X, Fumaria (Fumitory) 4X, Hyssopus (Hyssop) 4X, Myristica fragrans (Nutmeg) 4X, Piper album (White pepper) 4X, Syzygium aromaticum (Clove) 4X, Thymus vulgaris (Garden thyme) 4X, Zingiberis (Ginger) 4X; 5 gm China (Peruvian bark) 4X, Cinnamomum cassia (Cinnamon) 4X, Coriandrum (Coriander) 4X, Crocus sativus (Saffron) 4X, Myristica fragrans (Nutmeg) 4X, Origanum vulgare (Oregano) 4X, Piper longum (Long pepper) 4X, Piper nigrum (Black pepper) 4X, Vanilla (Vanilla beans) 4X; Levico (Mineral spring water) 8X, Ambra grisea (Amber gris) 10X, Hematite (Red iron ore) 11X, Prunus spin. cum Ferro (Blackthorn, Iron) 11X, Aurum met. (Metallic gold) 12X

Inactive Ingredient

Inactive Ingredients: Water, Salt, Glycerin, Organic cane sugar

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: 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.

Otc - Questions

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120

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