Indications & Usage
Directions: FOR ORAL USE ONLY.
Threefold Balance
FDA Label NDC 48951-9364
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 Threefold Balance (NDC 48951-9364). 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
Ages 12 and older: 1-2 tablets 3-4 times daily. Ages 2-11: 1 tablet. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredients: Olibanum (Rubber resin from wood of incense tree) 2X, Myrrha (Myrrh resin) 2X, Aurum metallicum (Metallic gold) 6X
Inactive Ingredient
Inactive Ingredients: Lactose, Magnesium stearate
Otc - Purpose
Uses: For overall well-being. Temporary relief of environmental sensitivity. Calms and relieves stress.
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. Contains lactose. 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
Made by Uriel, East Troy, WI 53120
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