Indications & Usage Section
Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
Headache Pellet
FDA Label NDC 55714-2454
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 Headache (NDC 55714-2454). 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 - purpose section, otc - active ingredient section, inactive ingredient section, questions section, otc - pregnancy or breast feeding section, warnings section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
Otc - Purpose Section
Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
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.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose (lactose-free) pellets.
Questions Section
newtonlabs.net - Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
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 - Keep Out Of Reach Of Children Section
Keep out of reach of children
Package Label
Package Label (N013 P01)
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