FDA Label for Homeopathic Calm Drops
View Indications, Usage & Precautions
Homeopathic Calm Drops Product Label
The following document was submitted to the FDA by the labeler of this product Historical Remedies Llp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications
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.
Otc - Purpose
Directions
Adults and children over 8: Dissolve one Calm Drops lozenge in mouth. Repeat every half hour as needed.
Warnings
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.
Active Ingredients
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.
Inactive Ingredients
Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, Organic Vanilla Flavor.
4 calories per lozenge. 1 gram sugar per lozenge. No gluten added.
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