The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Calcium Composition (NDC 57520-0320). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS: Arnica montana 3X, Echinacea 3X, Boron gluconate 6X, 12X, Symphytum officinale 6X, 30X, Hekla lava 8X, 30X, Calcarea carbonica 12X, 30X, Calcarea fluorica 12X, 30X, Calcarea phosphorica 12X, 30X, Lycopodium clavatum 12X, 30X, Silicea 12X, 30X, 200X.
INDICATIONS: Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.
WARNINGS: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol
Distributed By:
SYNERGY FORMULAS, INC.
251 West Road
Campobello SC 29322
Synergy Formulas
CALCIUM COMPOSITION
HOMEOPATHIC
2 FL OZ (30 ML)
Calcium Composition (Mm1)
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