Arnica Betula B Pellet
FDA Label NDC 48951-1117

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 B (NDC 48951-1117). 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.

Label Section Quick Index

Indications & Usage

Directions: FOR ORAL USE ONLY.

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 cort. (Silver birch, bark dried) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quad. (Bovine Quadrigeminal plate) 17X, Epiphysis (Bovine pineal body) 17X, Labyrinthus (Bovine inner ear) 17X, Medulla oblong. (Bovine Myelencephalon 17X, Nervus stat. (Bovine eighth cranial nerve) 17X, Arnica 30X, Onyx (Nat. Silicic acid with traces of iron oxide and carbon) 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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