The following Structured Product Label (SPL) was submitted to the FDA by Heel Inc for the product Spascupreel (NDC 50114-6129). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, indications and usage, warnings, dosage and administration, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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