FDA Label for Headache-migraine

View Indications, Usage & Precautions

Headache-migraine 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



Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.


Dosage & Administration Section



Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.


Otc - Active Ingredient Section



Equal parts of Apis mellifica 6x, Hypericum perforatum 6x, Thuja occidentalis 6x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga racemosa 15x, Coffea cruda 15x, Convallaria majalis 15x, Crotalus horridus 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Glonoinum 15x, Ignatia amara 15x, Lachesis mutus 15x, Mercurius vivus 15x, Naja tripudians 15x, Nux vomica 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria canadensis 15x, Secale cornutum 15x, Vipera berus 15x, Elaps corallinus 30x.


Otc - Purpose Section



Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.


Inactive Ingredient Section



USP Purified water. USP Gluten-free, non-GMO, organic cane alcohol 20%.


Questions Section



newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013


Warnings Section



WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.


Otc - Pregnancy Or Breast Feeding Section



If pregnant or breast-feeding, ask a doctor before use.


Otc - Keep Out Of Reach Of Children Section



Keep out of reach of children


Package Label




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