Indications:
For the temporary relief of minor
muscle spasms, menstrual cramps, intestinal colic.
Spascupreel
FDA Label NDC 62795-9493
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Spascupreel (NDC 62795-9493). 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 indications:, warnings:, directions:, inactive ingredients:, keep out of reach of children, purpose, active ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
* Please review the disclaimer below.
