Label: OHM RESPIRATORY LOWER TERRAIN- aconitum, aranea, bryonia, equisetum, eupatorium perf, hydrastis, juglans reg, kali bic, phosphorus, sarsaparrilla, sulphur liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 12, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    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.


  • INDICATIONS & USAGE

    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

    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.


  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    OTHER INFORMATION: Store at controlled room temperature. Tamper evident seal. Do not use if box seal is missing or broken.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Isotonic sodium chloride solution.


  • QUESTIONS

    Mfg. By: OHM PHARMA, INC. / Mineral Wells, TX 76067

    Made in USA

    www.ohmpharma.com

  • PURPOSE

    Acute or chronic functional ailments of the kidneys and/or urinary track relief

  • PRINCIPAL DISPLAY PANEL

    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 English

    Terrain Box Spanish

    Ampoule Box

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    Insert Spanish

  • INGREDIENTS AND APPEARANCE
    OHM RESPIRATORY LOWER TERRAIN 
    aconitum, aranea, bryonia, equisetum, eupatorium perf, hydrastis, juglans reg, kali bic, phosphorus, sarsaparrilla, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66096-172
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1 mL
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS9 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE7 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP5 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL7 [hp_X]  in 1 mL
    JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF6 [hp_X]  in 1 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS7 [hp_X]  in 1 mL
    SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT9 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-172-0612 in 1 BOX
    12.2 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/23/2015
    Labeler - OHM PHARMA INC. (030572478)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(66096-172)