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.
Insomnia
FDA Label NDC 55714-4404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Insomnia (NDC 55714-4404). 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 product name & indications section, direction section, active ingredient section, inactive ingredient section, questions? section, warnings section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package Label (R003 L01)
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