Label: COLOCYNTHIS HOMACCORD- gnaphalium and citrullus colocynthis fruit without seed injection
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Contains inactivated NDC Code(s)
NDC Code(s): 68275-320-10 - Packager: JENAHEXAL PHARMA GMBH
- Category: HUMAN PRESCRIPTION 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 September 9, 2009
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- DESCRIPTION
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- DOSAGE FORMS & STRENGTHS
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WARNINGS AND PRECAUTIONS
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 -
INDICATIONS & USAGE
1. Indications and Usage
1.1 Colocynthis-Homaccord® Injection Solution is classifed as a homeopathic combination drug.
1.2 Botanical ingredients: Colocynthis (bitter cucumber) Gnaphalium polycephalum (common everlasting)
1.3 Colocynthis-Homaccord® Injection Solution is indicated for neuralgia of various origins and locations, especially sciatic neuralgia, intercostal neuralgia and intervertebral disc disorders. -
DOSAGE & ADMINISTRATION
2. Dosage and Administration
2.1 The dosage schedules listed below can be used as a general guide for the administration of Colocynthis-Homaccord® Injection Solution. Colocynthis-Homaccord® 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, otherwise 1 ampule, 1 to 3 times per week IM/SC/IV/ID. Children ages 2 to 6 receive ½ the adult dosage.
Discard unused solution.Colocynthis-Homaccord® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Colocynthis-Homaccord® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefy. Colocynthis-Homaccord® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Colocynthis-Homaccord® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Colocynthis-Homaccord® Injection Solution is a clear, colorless solution. Discolored solutions should be discarded.
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WARNINGS AND PRECAUTIONS
3. Warnings and Precautions
3.1 Colocynthis-Homaccord® Injection Solution exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects.
3.2 No harmful or potentially harmful side effects such as central nervous system depression are known. Colocynthis-Homaccord® Injection Solution is generally well-tolerated, however, if symptoms persist or worsen discontinue use.
3.3 Teratogenic effects: In general, homeopathic drugs are not known to cause direct or indirect harm to the fetus. 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.
3.4 Drug Interactions: None known
3.5 Drug / Laboratory Test Interaction: None known
3.6 Carcinogenesis, mutagenesis, impairment of fertility: Not applicable
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USE IN SPECIFIC POPULATIONS
4. Use in Specifc Populations
4.1 Pediatric Use: Colocynthis-Homaccord® Injection Solution can be safely administered to children as young as 2 years. (see Dosage and Administration)
4.2 Nursing Mothers: It is not known whether any of the ingredients in Colocynthis-Homaccord® Injection Solution are excreted in human milk. However, because many drugs are excreted in human milk, Colocynthis-Homaccord® Injection Solution should be administered with caution to nursing mothers.
4.3 Geriatric use: Colocynthis-Homaccord® Injection Solution is safe to use in adults 12 years and older. (see Dosage and Administration) - CLINICAL PHARMACOLOGY
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- HOW SUPPLIED
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLOCYNTHIS HOMACCORD
gnaphalium and citrullus colocynthis fruit without seed injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68275-320 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GNAPHALIUM (UNII: BGI20Z6M57) (GNAPHALIUM - UNII:BGI20Z6M57) GNAPHALIUM 3 [hp_X] in 1.1 mL GNAPHALIUM (UNII: BGI20Z6M57) (GNAPHALIUM - UNII:BGI20Z6M57) GNAPHALIUM 10 [hp_X] in 1.1 mL GNAPHALIUM (UNII: BGI20Z6M57) (GNAPHALIUM - UNII:BGI20Z6M57) GNAPHALIUM 30 [hp_X] in 1.1 mL GNAPHALIUM (UNII: BGI20Z6M57) (GNAPHALIUM - UNII:BGI20Z6M57) GNAPHALIUM 200 [hp_X] in 1.1 mL CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED 4 [hp_X] in 1.1 mL CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED 10 [hp_X] in 1.1 mL CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED 30 [hp_X] in 1.1 mL CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT WITHOUT SEED 200 [hp_X] in 1.1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68275-320-10 1.1 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/09/2009 Labeler - JENAHEXAL PHARMA GMBH (344282590) Establishment Name Address ID/FEI Business Operations JENAHEXAL PHARMA GMBH 344282590 manufacture