Spascupreel

Dosage Form: injection

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.

Spascupreel 1.1ml Injection

Spascupreel Description

Injection Solution Ingredient Information: Each 1.1 ml ampule contains: Aconitum napellus 6X 2.2 mcl; Ammonium bromatum 4X 1.1 mcl; Colocynthis 4X 1.1 mcl; Atropinum sulphuricum 6X 1.1 mcl; Gelsemium sempervirens 6X 1.1 mcl; Magnesia phosphorica 6X 1.1 mcl; Veratrum album 6X 1.1 mcl; Passiflora incarnata 2X 0.55 mcl; Chamomilla 3X 0.55 mcl; Agaricus muscarius 4X 0.55 mcl; Cuprum sulphuricum 6X 0.55 mcl. Inactive Ingredients: Sterile isotonic sodium chloride solution.

INDICATION AND USAGE

              

Spascupreel® Injection Solution is indicated for the temporary relief of muscle spasms, anywhere in the body including abdominal cramps, menstrual cramps, spasmodic cough, intestinal colic, and smooth musculature spasms.

Spascupreel® Injection Solutionis classified as a homeopathic combination drug.

Botanical ingredients:
Aconitum napellus (Monk's hood, Wolfsbane)
Colocynthis (Bitter cucumber)
Veratrum album (White hellebore)
Passiflora incarnata (Passion flower)
Chamomilla (German chamomile)
Agaricus muscarius (Fly agaria)
Gelsemium sempervirens (Yellow jasmine)

Mineral ingredients:
Ammonium bromatum (Ammonium bromide)
Atropinum sulphuricum (Atropine sulfate)
Magnesia phosphorica (Magnesium phosphate)
Cuprum sulphuricum (Copper sulfate)









Warnings and Precautions



If new syptoms occur, or if redness, pain or swelling at the puncture site persists, the patient should be carefully re-evaluated because these could be signs of a more 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.



Adverse Reactions

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 Spascupreel® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

Spascupreel - Clinical Pharmacology

The exact mechanism of action of Spascupreel® Injection Solution is not fully understood.

DOSAGE

Injections: 1.1 ml ampule

Spascupreel_injectable box_09.jpg

Spascupreel 
aconitum napellus and ammonium bromide and citrullus colocynthis fruit pulp and atropine sulfate and gelsemium sempervirens root and magnesium phosphate, dibasic trihydrate and veratrum album root and passiflora incarnata flower and chamomile and amanita muscaria var. muscaria and cupric sulfate and injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52919-141
Route of Administration INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_X]  in 1.1 mL
AMMONIUM BROMIDE (AMMONIUM BROMIDE) AMMONIUM BROMIDE 4 [hp_X]  in 1.1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X]  in 1.1 mL
ATROPINE SULFATE (SULFATE ION) ATROPINE SULFATE 6 [hp_X]  in 1.1 mL
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]  in 1.1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (PHOSPHATE ION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X]  in 1.1 mL
VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT 6 [hp_X]  in 1.1 mL
PASSIFLORA INCARNATA FLOWER (PASSIFLORA INCARNATA FLOWER) PASSIFLORA INCARNATA FLOWER 2 [hp_X]  in 1.1 mL
CHAMOMILE (CHAMOMILE) CHAMOMILE 3 [hp_X]  in 1.1 mL
AMANITA MUSCARIA VAR. MUSCARIA (AMANITA MUSCARIA VAR. MUSCARIA) AMANITA MUSCARIA VAR. MUSCARIA 4 [hp_X]  in 1.1 mL
CUPRIC SULFATE (SULFATE ION) CUPRIC SULFATE 6 [hp_X]  in 1.1 mL
Packaging
# Item Code Package Description
1 NDC:52919-141-10 1.1 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/20/2011
Labeler - Hameln Pharma GmbH (315869123)
Revised: 01/2011
 
Hameln Pharma GmbH
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