Spascupreel

Manufacturer
MediNatura Inc | Biologische Heilmittel Heel
Effective date
2023-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:21:10

Label at a glance#

ProductSpascupreel
Active ingredientACONITUM NAPELLUS WHOLE, AMANITA MUSCARIA FRUITING BODY, AMMONIUM BROMIDE, 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
Label structure8 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Indications:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

 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:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

 Lactose, Magnesium stearate

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Purpose

OTC - PURPOSE SECTION

Muscle Spasms
& Cramps

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spascupreel.jpgSpascupreel.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
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11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-9493-2Spascupreel100 in 1 BOTTLETABLET1002
62795-9493-2Spascupreel1 in 1 CARTONTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-9493SPASCUPREEL (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]2Legacy NDC, 2 package rows20230515_854497b7-08a6-45ce-9761-cddb264b07dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-9493-2EA - Each62795-9493d16e132f-4f76-48a0-ac24-b939509041e912022-05-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-949362795-9493-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cae3666b-3400-45b1-ac08-4e1c40e7eb1d854497b7-08a6-45ce-9761-cddb264b07dd2023-05-10WarningsExact identifier
spl id: cae3666b-3400-45b1-ac08-4e1c40e7eb1d
spl set id: 854497b7-08a6-45ce-9761-cddb264b07dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.