Label: T-RELIEF PRO SPASM- aconitum napellus,amanita muscaria fruiting body, ammonium bromide, atropine sulfate, atropa belladonna, matricaria recutita, citrullus colocynthis fruit pulp,magnesium phosphate, dibasic trihydrate, passiflora incarnata flowering top, and 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 June 29, 2021

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  • ACTIVE INGREDIENT

    Each tablet contains: *Aconitum napellus 6X 20%, *Agaricus muscarius 4X 5%, Ammonium bromatum 4X 10%, Atropinum sulphuricum 6X 10%, *Belladonna 6X 22%, *Chamomilla 2X 0.67%, *Colocynthis 3X 1.33%, Cuprum sulphuricum 6X 5%, *Gelsemium sempervirens 6X 10%, Magnesia phosphorica 6X 10%, *Passiflora incarnata 2X 5%, *Veratrum album 5X 1.33%.

    *Natural Ingredients

  • INACTIVE INGREDIENT

    Lactose, Magnesium stearate

  • USES

    For the temporary relief of minor: Menstrual Cramps • Abdominal Bloating • Muscle Spasms Leg Cramps

  • DIRECTIONS

    Adults and children 12 years and older: Chew 2 tablets every 4 hours, or use as directed by you health professional. Children 4 to 11 years: Chew 1-2 tablets every 4 hours,or as directed by your health professional . For children under 4 years, use as directed by your health professional.

  • WARNINGS

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Indications

    Relieves

    • Menstrual Cramps

    • Abdominal Bloating

    • Muscle Spasm

    Leg Cramps

  • PRINCIPAL DISPLAY PANEL

    T-Relief Pro Spasm.jpg

  • INGREDIENTS AND APPEARANCE
    T-RELIEF PRO SPASM 
    aconitum napellus,amanita muscaria fruiting body, ammonium bromide, atropine sulfate, atropa belladonna, matricaria recutita, citrullus colocynthis fruit pulp,magnesium phosphate, dibasic trihydrate, passiflora incarnata flowering top, and veratrum album root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS6 [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]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA2 [hp_X]
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP3 [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 ROOT5 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1040-290 in 1 BOTTLE; Type 0: Not a Combination Product11/16/201704/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/16/201704/30/2025
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1040)
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