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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS AND USAGE

For the temporary relief of minor:

  • Menstrual Cramps
  • Abdominal Bloating
  • Muscle Spasms

WARNINGS

If pregnant or breast-feeding, ask a healthcare provider 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.

DOSAGE AND ADMINISTRATION

Standard Dosage:

Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

Children 4 to 11 years: 2 tablets per day, taking 1 tablet every 6 to 8 hours.

For children under 4 years, consult your healthcare provider.

Initial Dosage:

Adults and children 12 years and older: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.

Children 4 to 11 years: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 8 tablets in 24 hours.

For children under 4 years, consult your healthcare provider.

Allow tablets to dissolve completely in the mouth, do not swallow.

ACTIVE INGREDIENTS

Each tablet contains: Aconitum napellus 6X, Agaricus muscarius 4X, Ammonium bromatum 4X, Atropinum sulphuricum 6X, Chamomilla 3X, Colocynthis 4X, Cuprum sulphuricum 6X, Gelsemium sempervirens 6X, Magnesia phophorica 6X, Passiflora incarnata 2X, Veratrum album 6X.

INACTIVE INGREDIENTS

Lactose and Magnesium stearate.

PURPOSE

  • Menstrual Cramps, Abdominal Bloating, Muscle Spasms 

Spascupreel Tablet v.2.jpg

SPASCUPREEL 
aconitum napellus, amanita muscaria fruiting body, ammonium bromide, atropine sulfate, matricaria recutita, citrullus colocynthis fruit pulp, cupric sulfate, gelsemium sempervirens root, magnesium phosphate, dibasic trihydrate, passiflora incarnata flowering top and veratrum album root tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50114-6128
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS6 [hp_X]
AMANITA MUSCARIA FRUITING BODY (AMANITA MUSCARIA FRUITING BODY) AMANITA MUSCARIA FRUITING BODY4 [hp_X]
AMMONIUM BROMIDE (BROMIDE ION) AMMONIUM BROMIDE4 [hp_X]
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE6 [hp_X]
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA3 [hp_X]
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP4 [hp_X]
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP2 [hp_X]
VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code Heel
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-6128-2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/198408/20/2014
Labeler - Heel Inc. (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Inc.102783016manufacture(50114-6128)

Revised: 8/2014
Document Id: 96ec0d32-4826-454c-b9a0-f0c5492c6766
Set id: 65a37a7e-8df9-4eb7-b90e-619767dd6037
Version: 3
Effective Time: 20140820
 
Heel Inc.