Label: 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 flowering top and matricaria recutita and amanita muscaria var. muscaria fruiting body and cupric sulfate solution

  • Category: HUMAN OTC 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 May 9, 2012

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  • ACTIVE INGREDIENTS

    Active ingredients: Each 1.1 ml contains: Aconitum napellus 6X 2.2 mcl; Ammonium bromatum 4X, Colocynthis 4X, Atropinum sulphuricum 6X, Gelsemium sempervirens 6X, Magnesia phosphorica 6X, Veratrum album 6X 1.1 mcl each; Passiflora incarnata 2X, Chamomilla 3X, Agaricus muscarius 4X, Cuprum sulphuricum 6X 0.55 mcl each.
  • PURPOSE

    Abdominal cramps, Menstrual cramps, Spasmodic cough, Intestinal colic
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of the reach of children.
  • INDICATIONS AND USAGE

    Indications: For the temporary relief of muscle spasms anywhere in the body such as:
    • Abdominal cramps
    • Menstrual cramps
    • Spasmodic cough
    • Intestinal colic
  • WARNINGS

    Warnings: If symptoms persist or worsen, a health care professional should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.
  • DOSAGE AND ADMINISTRATION

    Dosasge: Adults and children above 6 years: In general 1 vial 1 - 3 times daily, or as directed by a physician. Children up to 6 years: 1/2 the adult dosage. Discard unused solution.
  • INACTIVE INGREDIENTS

    Inactive ingredients: Isotonic sodium chloride solution
  • PRINCIPAL DISPLAY PANEL

    Spascupreel Oral Vial.jpg







  • INGREDIENTS AND APPEARANCE
    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 flowering top and matricaria recutita and amanita muscaria var. muscaria fruiting body and cupric sulfate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-6129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [hp_X]  in 1.1 mL
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (AMMONIUM BROMIDE - UNII:R0JB3224WS) AMMONIUM BROMIDE4 [hp_X]  in 1.1 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]  in 1.1 mL
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (SULFATE ION - UNII:7IS9N8KPMG) ATROPINE SULFATE6 [hp_X]  in 1.1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 1.1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838, PHOSPHATE ION - UNII:NK08V8K8HR) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]  in 1.1 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT6 [hp_X]  in 1.1 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]  in 1.1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1.1 mL
    AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY4 [hp_X]  in 1.1 mL
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L, SULFATE ION - UNII:7IS9N8KPMG) CUPRIC SULFATE6 [hp_X]  in 1.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-6129-610 in 1 CARTON
    11.1 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/31/1993
    Labeler - Heel Inc (102783016)
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