Indications & Usage Section
Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
Headache-migraine Liquid
FDA Label NDC 55714-4798
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-migraine (NDC 55714-4798). 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.
Label Section Quick Index
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
Package Label (R023 L01)
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