{"adverse_reactions":["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"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The exact mechanism of action of Spascupreel® Injection Solution is not fully understood."],"description":["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."],"dosage_forms_and_strengths":["DOSAGE Injections: 1.1 ml ampule"],"effective_time":"20110120","id":"2f4d1e39-ed6a-4b39-ba5a-00e21ead2874","indications_and_usage":["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)"],"openfda":{},"overdosage":["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."],"package_label_principal_display_panel":["Spascupreel_injectable box_09.jpg Spascupreel_injectable box_09.jpg"],"set_id":"27fe290e-d9d1-42f6-b22b-65e50312b42b","spl_product_data_elements":["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 ACONITUM NAPELLUS ACONITUM NAPELLUS AMMONIUM BROMIDE AMMONIUM BROMIDE CITRULLUS COLOCYNTHIS FRUIT PULP CITRULLUS COLOCYNTHIS FRUIT PULP ATROPINE SULFATE SULFATE ION GELSEMIUM SEMPERVIRENS ROOT GELSEMIUM SEMPERVIRENS ROOT MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE PHOSPHATE ION VERATRUM ALBUM ROOT VERATRUM ALBUM ROOT PASSIFLORA INCARNATA FLOWER PASSIFLORA INCARNATA FLOWER CHAMOMILE CHAMOMILE AMANITA MUSCARIA VAR. MUSCARIA AMANITA MUSCARIA VAR. MUSCARIA CUPRIC SULFATE SULFATE ION"],"version":"1","warnings_and_cautions":["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."]}