The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Calm Plus (NDC 62795-1115). 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, uses, active ingredients, inactive ingredients, directions, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
If symptoms persist or worsen, or if sleeplessness persists continuously for more than 2 weeks, consult your doctor.
Insomnia may be a symptom of serious underlying medical illness.
Do not use if sensitivity to Calm Plus or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.
For the temporary relief of:
• Simple nervous tension
• Restlessness
• Trouble sleeping
Active Ingredients:
Each tablet contains equal parts of Avena sativa 2X; Chamomilla 2X; Humulus lupulus 2X; Passiflora incarnata 2X; Calcarea phosphorica 6X; Kali phosphoricum 6X; Kali sulphuricum 6X; Magnesia phosphorica 6X; Natrum muriaticum 6X; Natrum sulphuricum 6X; Zincum valerianicum 6X; Coffea cruda 12X; Nux vomica 12X; Sulphur 12X
Inactive Ingredients:
Lactose, Magnesium stearate
Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.
For the temporary relief of:
• Simple nervous tension
• Restlessness
• Trouble sleeping
* Please review the disclaimer below.
