FDA Label for Insomnia

View Indications, Usage & Precautions

Insomnia Product Label

The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. 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.

Product Name & Indications Section



Insomnia   Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.


Direction Section



Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional.


Active Ingredient Section



Absinthium 15x, Anacardium occidentale 15x, Arg. nit. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x,Calc. carb. 15x, Camphora 15x, Chamomilla 15x, Cimicifuga 15x, Cinchona 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x,Humulus 15x, Hyoscyamus 15x, Ignatia 15x, Kali brom.15x, Nux vom. 15x, Passiflora 15x, Pulsatilla 15x, Scutellaria lateriflora 15x,Sepia 15x, Thuja occ. 15x, Passiflora 8x, Valeriana 8x, Passiflora 3x,Valeriana 3x.


Inactive Ingredient Section



Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%. 


Questions? Section



www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 


Warnings Section



Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.


Otc - Pregnancy Or Breast Feeding Section



Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.


Otc - Keep Out Of Reach Of Children Section



Keep out of reach of children


Package Label




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