Nervousness - Anxiety
FDA Label NDC 55714-2245

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 Nervousness - Anxiety (NDC 55714-2245). 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 & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Indications & Usage Section

Nervousness - Anxiety  Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) 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

Aconitum nap. 15x, Ambra 15x, Anacardium orientale 15x, Arg. nit. 15x, Asafoetida 15x, Bryonia 15x, Chamomilla 15x, Cimicifuga 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x, Hyoscyamus 15x, Hypericum 15x, Ignatia 15x, Kali phos. 15x, Nux vom. 15x, Sambucus nig. 15x, Strychninum 15x, Theridion 15x, Valeriana 15x, Passiflora 3x, Valeriana 3x.

Otc - Purpose Section

Formulated for associated symptoms such as nervous discomfort, irritability, racing thoughts, restlessness, tension and worry.

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

Package Label (N070 P01)

Package Label (N070 P01)

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