Headache 4798l

Headache 4798l
SPL v2
SPL
SPL Set ID 994a037b-7165-3a1e-e053-2a95a90ad7ff
Route
ORAL
Published
Effective Date 2019-09-02
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 (6 [hp_X]) Bryonia Alba Root Centaurea Benedicta Black Cohosh Arabica Coffee Bean Convallaria Majalis Crotalus Horridus Horridus Venom Digitalis Lachesis Muta Venom Gelsemium Sempervirens Root Nitroglycerin Strychnos Ignatii Seed 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
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-02
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

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

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 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)

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

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 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section (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 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)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:09:56.607123 · Updated: 2026-03-14T23:15:01.065113