Arnica Betula A
FDA Label NDC 48951-1115

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 Arnica Betula A (NDC 48951-1115). 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 dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Dosage & Administration

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: Betula (Silver birch leaves) 3X, Betula (Silver birch bark) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quadrig. (Bovine Quadrigeminal plate) 17X, Hypophysis (Bovine pituitary gland) 17X, Iris -bovis (Bovine iris) 17X, Medulla oblong. (Bovine Myelencephalon) 17X, Nervus opticus (Bovine second cranial nerve) 17X, Retina et chor. (Bovine retina and choroid) 17X, Thalamus (Bovine thalamus) 17X, Arnica 30X, Chrysolith (Silicate of magnesium and iron) 30X, Formica (Red wood ant) 30X, Plumbum mellitum (Lead with honey) 30X

Inactive Ingredient

Inactive Ingredient: Organic sucrose

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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.

Otc - Questions

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

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