The following Structured Product Label (SPL) was submitted to the FDA by Ohm Pharma Inc. for the product Ohm Respiratory Lower Terrain (NDC 66096-172). 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: Aconitum 6X, Aranea 9X, Bryonia 6X, Equisetum 7X, Eupatorium Perf 5X, Hydrastis7X, Juglans Reg 6X, Kali Bic 12X, Phosphorus 7X, Sarsaparrilla 9X, Sulphur 8X.
*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
USES: Temporarily relieves lower respiratory track mucosa irritation or secretion due to diverse etiology.**
**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, consult a physician. A persistent cough may be a sign of a serious condition. If cough persists for more than 5 days, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
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: 66096-172-06
OHM RESPIRATORY LOWER TERRAIN
HOMEOPATHIC MEDICINE
Pharmaceutical Grade. Professional use only.
CONTENTS: 12 oral ampoules of 2.2 ml each.
Terrain Box Spanish (Ohm Resb)
* Please review the disclaimer below.
