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.

----------

Neuralgo-Rheum 1.1ml Injection

DESCRIPTION

 Each 1.1 ml solution for injection ampule contains:
 Active Ingredients:
 Ingredient name Potency Quantity Final dilution
 Causticum 10X 1.1 µl 12.99
 Causticum 30X 1.1 µl 32.99
 Causticum 200X 1.1 µl 203.00
 Colchicum autumnale 10X 1.1 µl 12.99
 Colchicum autumnale 30X 1.1 µl 32.99
 Colchicum autumnale 200X 1.1 µl 203.00
 Colocynthis 10X 1.1 µl 12.99
 Colocynthis 30X 1.1 µl 32.99
 Ferrum metallicum 10X 1.1 µl 12.99
 Ferrum metallicum 30X 1.1 µl 32.99
 Gnaphalium polycephalum 6X 3.3 µl 8.52
 Gnaphalium polycephalum 10X 3.3 µl 12.52
 Gnaphalium polycephalum 30X 3.3 µl 32.52
 Lithium benzoicum 10X 1.1 µl 12.99
 Lithium benzoicum 30X 1.1 µl 32.99
 Rhus toxicodendron 10X 1.1 µl 12.99
 Rhus toxicodendron 30X 1.1 µl 32.99
 Spiraea ulmaria 10X 1.1 µl 12.99
 Spiraea ulmaria 30X 1.1 µl 32.99

List of Excipients:

Water for injection 1,072.5 μl

Sodium Chloride 10.3 μl

INDICATIONS AND USAGE

Neuralgo-Rheum® Injection Solution is a homeopathic drug product indicated for the treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.

DOSAGE AND ADMINISTRATION

General Considerations

The dosage schedules listed below can be used as a general guide for the administration of Neuralgo-Rheum® Injection Solution.

• Neuralgo-Rheum® Injection Solution may be administered s.c., i.d., i.m., or i.v..

• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

• Draw up required dose into syringe.

• Discard any unused ampule contents. Do not reuse ampule.

Standard Dosage:

Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.

Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.

Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.

Acute Dosage:

Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.

Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.

Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.

CONTRAINDICATIONS

Neuralgo-Rheum® Injection Solution is contraindicated in patients with known hypersensitivity to Neuralgo-Rheum® or any of its ingredients.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

ADVERSE REACTIONS

Post-marketing Experience

  • No adverse events have been reported with a causal relationship to Neuralgo-Rheum® Injection Solution.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203

info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under Description.

Neuralgo-Rheum Inj. Carton v.2.jpg

NEURALGO RHEUM 
pseudognaphalium obtusifolium, causticum, colchicum autumnale bulb, citrullus colocynthis fruit pulp, iron, lithium benzoate, 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 CATION) 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 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-7070-110 in 1 CARTON
11.1 mL in 1 AMPULE
2NDC:50114-7070-23 in 1 CARTON
21.1 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: 6/2013
 
Heel Inc