The following Structured Product Label (SPL) was submitted to the FDA by Synergy Formulas, Inc. for the product Calming Composition (NDC 43772-0044). 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:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
HUMULUS LUPULUS 1X, 3X, VALERIANA OFFICINALIS 1X, 3X, AVENA SATIVA 1X, 6X, 30X, SCUTELLARIA LATERIFLORA 2X, 3X, SUMBUL 3X, MELILOTUS OFFICINALIS 3X, 6X, PASSIFLORA INCARNATA 3X, 6X, PHOSPHORUS 6X, 8X, 12X, IGNATIA AMARA 6X, 12X, MOSCHUS 8X, 10X, ZINCUM METALLICUM 8X, 12X, GLANDULA SUPRARENALIS SUIS 8X, 30X, HYPOTHALAMUS (SUIS) 8X, 30X, PULSATILLA (VULGARIS) 30X, ACONITUM NAPELLUS 30X, 100X, FERULA GLAUCA 6C
Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.
Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.
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.
Do not use if tamper evident seal is broken or missing.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Demineralized Water, 25% Ethanol
Distributed by:
SYNERGY FORMULAS, INC.
251 West Road
Campobello, SC 29322
Synergy Formulas
CALMING COMPOSITION
HOMEOPATHIC
2 FL OZ (60 ml)
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