SPASCUPREEL - aconitum napellus and ammonium bromide and citrullus colocynthis fruit pulp and atropine sulfate and gelsemium sempervirens root and magnesium phosphate, dibasic trihydrate and veratrum album root and passiflora incarnata flowering top and matricaria recutita and amanita muscaria var. muscaria fruiting body and cupric sulfate solution
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 1.1ml Oral Vial

ACTIVE INGREDIENTS

Active ingredients: Each 1.1 ml contains: Aconitum napellus 6X 2.2 mcl; Ammonium bromatum 4X, Colocynthis 4X, Atropinum sulphuricum 6X, Gelsemium sempervirens 6X, Magnesia phosphorica 6X, Veratrum album 6X 1.1 mcl each; Passiflora incarnata 2X, Chamomilla 3X, Agaricus muscarius 4X, Cuprum sulphuricum 6X 0.55 mcl each.

PURPOSE

Abdominal cramps, Menstrual cramps, Spasmodic cough, Intestinal colic

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

Indications: For the temporary relief of muscle spasms anywhere in the body such as:

Abdominal cramps
Menstrual cramps
Spasmodic cough
Intestinal colic

WARNINGS

Warnings: If symptoms persist or worsen, a health care professional should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

DOSAGE AND ADMINISTRATION

Dosasge: Adults and children above 6 years: In general 1 vial 1 - 3 times daily, or as directed by a physician. Children up to 6 years: 1/2 the adult dosage. Discard unused solution.

INACTIVE INGREDIENTS

Inactive ingredients: Isotonic sodium chloride solution

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50114-6129
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_X] in 1.1 mL
AMMONIUM BROMIDE (UNII: R0JB3224WS) (AMMONIUM BROMIDE - UNII:R0JB3224WS)	AMMONIUM BROMIDE	4 [hp_X] in 1.1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	4 [hp_X] in 1.1 mL
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (SULFATE ION - UNII:7IS9N8KPMG)	ATROPINE SULFATE	6 [hp_X] in 1.1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X] in 1.1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838, PHOSPHATE ION - UNII:NK08V8K8HR)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	6 [hp_X] in 1.1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	6 [hp_X] in 1.1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X] in 1.1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	3 [hp_X] in 1.1 mL
AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY	4 [hp_X] in 1.1 mL
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L, SULFATE ION - UNII:7IS9N8KPMG)	CUPRIC SULFATE	6 [hp_X] in 1.1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description
Packaging
1	NDC:50114-6129-6	10 in 1 CARTON
1		1.1 mL in 1 VIAL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/1993

Labeler - Heel Inc (102783016)