Indications & Usage
Directions: FOR ORAL USE.
Betula E Fol. 4 Special Order
FDA Label NDC 48951-2124
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 E Fol. 4 Special Order (NDC 48951-2124). 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
Dosage & Administration
Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.
Otc - Active Ingredient
Active Ingredient: Betula e fol. (Silver birch leaf) 2X
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: 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.
Otc - Questions
Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
www.urielpharmacy.com
Package Label.Principal Display Panel
Betulaefol4soampules (Betulaefol4soampules)
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