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
MediNatura Inc

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.

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Spascupreel

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

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62795-9493
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	6 [hp_X]
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	4 [hp_X]
AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06)	AMMONIUM BROMIDE	4 [hp_X]
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	6 [hp_X]
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	3 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	4 [hp_X]
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	6 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	H
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:62795-9493-2	1 in 1 CARTON	02/17/2022
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/17/2022

Labeler - MediNatura Inc (079324099)

Name	Address	ID/FEI	Business Operations
Establishment
Biologische Heilmittel Heel		315635359	manufacture(62795-9493)