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.
Indications & Usage 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.
Dosage & Administration Section
Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Active Ingredient Section
Absinthium 10x, Anacardium orientale 10x, Arg. nit. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Calc. carb. 10x, Camphora 10x, Chamomilla 10x, Cimicifuga 10x, Cinchona 10x, Coffea cruda 10x, Cypripedium 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 10x, Ignatia 10x, Kali brom.10x, Nux vom. 10x, Passiflora 10x, Pulsatilla 10x, Scutellaria lateriflora 10x, Sepia 10x, Thuja occ. 10x, Passiflora 3x, Valeriana 3x.
Otc - Purpose Section
Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
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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