Betula Spiraea
FDA Label NDC 48951-2068

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 Betula Spiraea (NDC 48951-2068). 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.

Dosage & Administration

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

Otc - Active Ingredient

Active Ingredients: Betula e cort. decoct. (Silver birch, bark dried) 3X, Betula e fol. (Silver birch leaves) 3X, Spiraea (Meadowsweet) 3X, Mandragora (Mandrake) 4X, Galena (Lead glance) 7X, Formica (Red wood ant) 10X, Arnica 17X, Equisetum (Common horsetail) 17X

Inactive Ingredient

Inactive Ingredients: Water, Salt

Otc - Purpose

Use: Temporary relief of sore muscles.

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. Natural ingredients may cause color, scent and/or taste variation.

Otc - Questions

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

* Please review the disclaimer below.