The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Bhi Calming (NDC 62795-1006). 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 ingredient, inactive ingredients, purpose, uses, directions, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Each tablet contains: *Chamomilla 2X, *Coffea cruda 10X, *Humulus lupulus 2X, *Ignatia amara 8X, *Moschus 10X, *Nux vomica 30X, *Passiflora incarnata 2X, *Sulphur 12X, *Valeriana officinalis 2X, *Veratrum album 4X 30 mg each.
*Natural Ingredients
Lactose, Magnesium stearate
Calming Tablets
Relieves:
• Nervous Tension
• Irritability
• Sleeplessness
For the temporary relief of minor occassional simple nervous tension and irritability to help occassional sleeplessness
At first sign of symptoms: Adults and children 12 years and older:
1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.
Standard dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. For children under 12, consult your health professional.
Allow tablets to dissolve completely in the mouth, do not swallow.
Do not give to children under 12 years of age. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If sleeplessness or nervous tension persist continuously for more than two weeks, a health professional should be consulted. Insomnia may be a symptom of serious underlying medical illness. Do not use if known sensitivity to BHI Calming or any of its ingredients exists
* Please review the disclaimer below.
