Label: SPASCUPREEL- aconitum napellus whole, amanita muscaria fruiting body, ammonium bromide, atropine sulfate, atropine sulfate, matricaria chamomilla whole, citrullus colocynthis fruit pulp, cupric sulfate,gelsemium sempervirens root,magnesium phosphate, dibasic trihydrate,passiflora incarnata flowering top,veratrum album root tablet

  • 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 10, 2023

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  • Indications:

    For the temporary relief of minor
    muscle spasms, menstrual cramps, intestinal colic.

  • Warnings:

     If pregnant or breast-feeding, ask
    a health professional before use. Keep out of
    reach of children. If symptoms persist or worsen,
    a healthcare provider should be consulted. Do not
    use if known sensitivity to Spascupreel® or any of its
    ingredients exists.

  • Directions:

    Adults and children 4 years and
    older: 1-2 tablets 3 times per day or as directed by a
    health practitioner. Not to exceed 6 tablets per 24
    hours. Children under 4, as directed by a health
    professional. Allow to completely dissolve in the mouth.

  • Inactive ingredients:

     Lactose, Magnesium stearate

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Purpose

    Muscle Spasms
    & Cramps

  • Active ingredients:

     Each 300 mg tablet contains:
    *Aconitum napellus 6X 60mg, *Agaricus muscarius 4X
    15mg, Ammonium bromatum 4X 30mg, Atropinum
    sulphuricum 6X 30mg, *Chamomilla 3X 15mg,
    *Colocynthis 4X 30mg, Cuprum sulphuricum 6X 15mg,
    *Gelsemium sempervirens 6X 30mg, Magnesia
    phosphorica 6X 30mg, *Passiflora incarnata 2X 15mg,
    *Veratrum album 6X 30mg. *Natural

  • PRINCIPAL DISPLAY PANEL

    Spascupreel.jpg

  • INGREDIENTS AND APPEARANCE
    SPASCUPREEL 
    aconitum napellus whole, amanita muscaria fruiting body, ammonium bromide, atropine sulfate, atropine sulfate, matricaria chamomilla whole, citrullus colocynthis fruit pulp, cupric sulfate,gelsemium sempervirens root,magnesium phosphate, dibasic trihydrate,passiflora incarnata flowering top,veratrum album root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-9493
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE6 [hp_X]
    AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY4 [hp_X]
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE4 [hp_X]
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE6 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE3 [hp_X]
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-9493-21 in 1 CARTON02/17/2022
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/17/2022
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biologische Heilmittel Heel315635359manufacture(62795-9493)
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