Renes Betula
FDA Label NDC 48951-8125

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 Renes Betula (NDC 48951-8125). 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

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: Agropyron (Couch grass) 4X, Ononis (Restharrow) 2X, Petroselinum (Parsley leaf) 2X, Petroselinum (Parsley root) 2X, Thlaspi bursa pastoris (Shepherd’s purse) 2X, Uva ursi (Bearberry) 2X, Solidago (Goldenrod) 2X, Betula (Silver birch leaves) 4X, Equisetum (Common horsetail) 3X, Renes (Bovine kidneys) 6X, Sarothamnus (Broom) 3X, Cuprum met. (Copper) 8X

Inactive Ingredient

Inactive Ingredients: Distilled water, Propolis, Lactose

Otc - Purpose

Use: Temporary relief of urinary discomfort.

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. Contains traces of lactose. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

REFRIGERATE AFTER OPENING.
BEST WHEN USED WITHIN 30 DAYS OF OPENING.

Otc - Questions

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com

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