Headache 2598p

Headache 2598p
SPL v1
SPL
SPL Set ID 44ffb50a-7bfe-428b-e063-6394a90a9dcf
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Micrurus Corallinus Venom (30 [hp_X]) Arsenic Cation (3+) (15 [hp_X]) Atropa Belladonna (16 [hp_X]) Bryonia Alba Root (6 [hp_X]) Centaurea Benedicta Black Cohosh Arabica Coffee Bean Convallaria Majalis Crotalus Horridus Horridus Venom Digitalis Gelsemium Sempervirens Root Nitroglycerin Strychnos Ignatii Seed Lachesis Muta Venom Mercury Naja Naja Venom Strychnos Nux-vomica Seed Phosphorus Toxicodendron Pubescens Leaf Sanguinaria Canadensis Root Claviceps Purpurea Sclerotium Vipera Berus Venom Apis Mellifera Hypericum Perforatum Thuja Occidentalis Leafy Twig
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-12-02

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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.

Questions Section

newtonlabs.net - Questions? 800.448.7256

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

Otc Purpose Section

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

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

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 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 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 16x, Elaps 30x.

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


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800.448.7256

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

Otc Purpose Section (OTC - PURPOSE SECTION)

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

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

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

Dosage & Administration Section (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 Active Ingredient Section (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 16x, Elaps 30x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)