The following Structured Product Label (SPL) was submitted to the FDA by Ohm Pharma Inc. for the product Ohm Renal Terrain (NDC 66096-181). 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, other, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Apis Mellifica 12X, Aranea Diadema 8X, Berberis Vulgaris 12X, Cantharis 7X, Equisetum Hyemale 7X, Hydrastis Canadensis 6X, Juglans Regia 7X, Kali Bichromicum 10X, Mercurius Solubilis 12X, Sarsaparilla 8X, Solidago Virgaurea 6X.
*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
USES: Temporarily relieves acute or chronic functional ailments of the kidneys and/or urinary track.**
**This statement has not been evaluated by the FDA.
It is based on documented Homeopathic Materia Medica.
WARNINGS:
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional.
KEEP OUT OF THE REACH OF CHILDREN.
DIRECTIONS: To open ampoule snap top up and away from you. Using pipette place entire content under the tongue, hold it for 30 seconds and swallow.
POSOLOGY: Adults and children over 12 years: In acute conditions: 1 ampoule every 12 hours. In chronic conditions: 1 ampoule one to four times per week, or as directed by a health professional.
Children under 12 years use 1/2 the adult dose.
Discard unused solution. Solution does not contain any preservatives.
Not for injection.
OTHER INFORMATION: Store at controlled room temperature. Tamper evident seal. Do not use if box seal is missing or broken.
INACTIVE INGREDIENTS: Isotonic sodium chloride solution.
Mfg. By: OHM PHARMA, INC. / Mineral Wells, TX 76067
Made in USA
www.ohmpharma.com
Acute or chronic functional ailments of the kidneys and/or urinary track relief
NDC: 66096-181-06
OHM RENAL TERRAIN
HOMEOPATHIC MEDICINE
Pharmaceutical Grade. Professional use only.
CONTENTS: 12 oral ampoules of 2.2 ml each.
Terrain Box Label Spanish (Ohm Ren)
* Please review the disclaimer below.
