The following Structured Product Label (SPL) was submitted to the FDA by Historical Remedies Llp. for the product Homeopathic Calm Drops (NDC 57556-006). 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 indications, otc - purpose, directions, warnings, active ingredients, inactive ingredients, label image, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
For temporary relief of occasional anxiety, tension and irritability. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, Ignatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.
Equal volumes of each ingredient.
Adults and children over 8: Dissolve one Calm Drops lozenge in mouth. Repeat every half hour as needed.
If symptoms persist more than 7 days or worsen, consult a physician. Keep out of children's reach. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breast-feeding, ask a doctor before use. Do not use if shrink wrap is broken or missing.
Aconitum nap 6X, Arsenicum alb 30C, Calcarea carb 30X, Chamomilla 12X, lgnatia 30X, Kali carb 30C, Lachesis 12X, Natrum mur 12X, Nux vom 30C, Phosphoricum ac 3X, Pulsatilla 12C, Sepia 30C.
Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Organic Vanilla Flavor.
4 calories per lozenge. 1 gram sugar per lozenge. No gluten added.
* Please review the disclaimer below.
