Neuralgo-Rheum 1.1ml Injection

NEURALGO RHEUM - pseudognaphalium obtusifolium, causticum, colchicum autumnale bulb, citrullus colocynthis fruit pulp, iron, lithium benzoate, toxicodendron pubescens leaf and filipendula ulmaria root injection 
Heel Inc

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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DESCRIPTION

Injection Solution Ingredient Information: Each 1.1 ml ampule contains: Gnaphalium polycephalum 6X, 10X 30X 3.3 mcl each; Causticum 10X, 30X, 200X, Colchicum autumnale 10X, 30X, 200X, Colocynthis 10X, 30X, Ferrum metallicum 10X, 30X, Litihium benzoicum 10X, 30X, Rhus toxicodendron 10X, 30X, Spiraea ulmaria 10X, 30X, 1.1 mcl each. Inactive ingredient: Sterile isotonic sodium chloride solution.

INDICATIONS AND USAGE

Neuralgo-Rheum® Injection Solution is indicated for neuralgia, rheumatism of the soft tissues, arthritic conditions and intervertebral disc conditions.

DOSAGE AND ADMINISTRATION

The dosage schedules listed below can be used as a general guide for the administration of Neuralgo-Rheum® Injection Solution . Neuralgo-Rheum® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response to therapy.

Adults and children 7 years and older: in acute disorders, 1 ampule per day, otherwise1 ampule, 1 to 3 times per week IM/SC/IV/ID. Children ages 2 to 6 receive ½ the adult dosage.

Discard unused solution.

Neuralgo-Rheum® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Neuralgo-Rheum® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Neuralgo-Rheum® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Neuralgo-Rheum® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Neuralgo-Rheum® Injection Solution is a clear, colorless solution.

Discolored solutions should be discarded.

WARNINGS AND PRECAUTIONS

If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should be carefully re-evaluated because these could be signs of a serious condition.Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

OVERDOSAGE

Due to the low concentration of active ingredients in homeopathic preparations such as Neuralgo-Rheum® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

CLINICAL PHARMACOLOGY

The exact mechanism of action of Neuralgo-Rheum® Injection Solution is not fully understood.

Neuralgo_Rheum_Inj_Box.jpg


NEURALGO RHEUM 
pseudognaphalium obtusifolium and causticum and colchicum autumnale bulb and citrullus colocynthis fruit pulp and iron and lithium benzoate and toxicodendron pubescens leaf and filipendula ulmaria root injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-7070
Route of AdministrationINTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM6 [hp_X]  in 1.1 mL
CAUSTICUM (CAUSTICUM) CAUSTICUM10 [hp_X]  in 1.1 mL
COLCHICUM AUTUMNALE BULB (COLCHICUM AUTUMNALE BULB) COLCHICUM AUTUMNALE BULB10 [hp_X]  in 1.1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]  in 1.1 mL
IRON (IRON) IRON10 [hp_X]  in 1.1 mL
LITHIUM BENZOATE (LITHIUM BENZOATE) LITHIUM BENZOATE10 [hp_X]  in 1.1 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 1.1 mL
FILIPENDULA ULMARIA ROOT (FILIPENDULA ULMARIA ROOT) FILIPENDULA ULMARIA ROOT10 [hp_X]  in 1.1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:50114-7070-110 in 1 CARTON
11.1 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/08/2011
Labeler - Heel Inc (102783016)

Revised: 07/2011
 
Heel Inc