The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Hendel Homeopathic Calm (NDC 62795-1118). 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 warnings, keep out of reach of children, indications, active ingredients, inactive ingredient, dosage, uses, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if sensitivity to Homeopathic Calm or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately
KEEP OUT OF REACH OF CHILDREN
Restlessness Occasional and simple nervous tension
Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X
Lactose, Magnesium stearate
Adults 18 and over: 1 to 2 tablets sublingually or dissolved completely in mouth 30 to 60 minutes before bedtime or as directed by a physician.
For the temporary relief of:
• Restlessness
• Occasional simple nervous tension
* Please review the disclaimer below.
