The following Structured Product Label (SPL) was submitted to the FDA by Rubimed Ag for the product Emvita 16 (NDC 66343-103). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts Active Ingredients: (HPUS*) 16.7% of each
Aconitum napellus 800C
Ambra grisea 18LM
Eschscholtzia 16LM Secale 21X
Thymus gland 21X Zinc met 21X
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Uses: (†) Homeopathic remedy for general well being: feeling broken-hearted.
Warnings:
Stop use if symptoms persist or worsen.
If you are pregnant or breastfeeding, consult a healthcare professional prior to use.
Keep out of reach of children.
Directions: (adults & children 6 years & older)
Take 12 drops 2 times daily, or as recommended by your health care professional.
Other information: Store at 20 - 25°C
(68 - 77°F.) Do not use if box has been
tampered with, or if the safety seal of the
bottle is broken.
Inactive ingredients: Ethanol 20% USP,
Purified Water.
Manufactured by: OHM pharma, Inc, USA.
Distributed by: Privia Naturals, LLC.
9169 W State St #196
Garden City, ID 83714
www.privianaturals.com
[email protected] Product of USA.
NDC 66343-103-60
RUBIMED
Emvita 16
Homeopathic Medicine For
General Well-being:
Feeling Broken-Hearted
2.0 fl oz. 59mL 20% Ethanol
Homeopathic Medicine For
General Well-being:
Feeling Broken-Hearted
* Please review the disclaimer below.
