FDA Label for Headache

View Indications, Usage & Precautions

Headache 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. Sensitive persons begin with 1 drop and gradually increase to full dose.


Otc - Active Ingredient Section



Equal parts of Apis mel. 6x, Hypericum 6x, Thuja occ. 6x, Arsenicum alb.15x, Belladonna 15x, Bryonia 15x, Carduus ben. 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus hor. 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phos. 15x, Rhus tox. 15x, Sanguinaria 15x, Secale 15x, Vipera 15x, Elaps 30x.


Otc - Purpose Section



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


Inactive Ingredient Section



Inactive Ingredients: 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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