Food 2545p

Food 2545p
SPL v2
SPL
SPL Set ID 9af2d6f4-baa8-5da9-e053-2995a90a3dac
Route
ORAL
Published
Effective Date 2019-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (15 [hp_X]) Baptisia Tinctoria Root (6 [hp_X]) Lycoperdon Utriforme Fruiting Body (16 [hp_X]) Caffeine Capsicum Cinchona Officinalis Bark Cinnamon Protortonia Cacti Cynara Scolymus Leaf Alpine Strawberry Gelsemium Sempervirens Root Histamine Solidago Virgaurea Flowering Top Urtica Urens Ginger Mentha Piperita Abrus Precatorius Seed Juglans Regia Leaf Ustilago Maydis Lachesis Muta Venom Nutmeg Podophyllum Sulfur Astacus Astacus Glycyrrhiza Glabra Solanum Tuberosum Saccharomyces Cerevisiae Anhydrous Lactose Sepia Officinalis Juice Sucrose Egg Shell, Cooked Lycopodium Clavatum Spore Rhododendron Tomentosum Leafy Twig Ascorbic Acid Black Mustard Seed Solanum Nigrum Whole Anacardium Occidentale Fruit Solanum Lycopersicum Nitrite Ion Chloride Ion Anemone Pulsatilla Toxicodendron Pubescens Leaf Allylthiourea Iris Versicolor Root Ipecac Aconitum Napellus Amanita Muscaria Fruiting Body Onion Garlic Phosphorus Saccharin Antimony Cation (3+)
Inactive Ingredients
Sucrose Caramel

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-07-01
Description

Formulated for associated symptoms such as itching, swelling, headaches, indigestiion, vomiting and cramping.

Purpose

Formulated for associated symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

Medication Information

Purpose

Formulated for associated symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

Description

Formulated for associated symptoms such as itching, swelling, headaches, indigestiion, vomiting and cramping.

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 symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

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 itching, swelling, headaches, indigestiion, vomiting and cramping.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or 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 Iris versicolor 6x, Solidago virgaurea 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium cepa 15x, Allium sativum 15x, Antimonium crudum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bovista 15x, Caffeinum 15x, Capsicum annuum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Coccus cacti 15x, Cynara scolymus 15x, Fragaria vesca 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Ipecacuanha 15x, Jequerity 15x, Juglans regia 15x, Lachesis mutus 15x, Ledum palustre 15x, Lycopodium clavatum 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Ova tosta 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharinum 15x, Saccharum lactis 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica urens 15x, Ustilago maidis 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Torula cerevisiae 16x.

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 symtoms such as itching, swelling, headaches, indigestion, vomiting and cramping.

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 itching, swelling, headaches, indigestiion, vomiting and cramping.

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 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 Iris versicolor 6x, Solidago virgaurea 6x, Aconitum napellus 15x, Agaricus muscarius 15x, Allium cepa 15x, Allium sativum 15x, Antimonium crudum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bovista 15x, Caffeinum 15x, Capsicum annuum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Coccus cacti 15x, Cynara scolymus 15x, Fragaria vesca 15x, Gelsemium sempervirens 15x, Histaminum hydrochloricum 15x, Ipecacuanha 15x, Jequerity 15x, Juglans regia 15x, Lachesis mutus 15x, Ledum palustre 15x, Lycopodium clavatum 15x, Mentha piperita 15x, Natrum muriaticum 15x, Nux moschata 15x, Ova tosta 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharinum 15x, Saccharum lactis 15x, Sepia 15x, Sulphur 15x, Thiosinaminum 15x, Urtica urens 15x, Ustilago maidis 15x, Zingiber officinale 15x, Anacardium occidentale 16x, Ascorbicum acidum 16x, Astacus fluviatilis 16x, Glycyrrhiza glabra 16x, Lycopersicum esculentum 16x, Natrum nitricum 16x, Saccharum officinale 16x, Sinapis nigra 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Torula cerevisiae 16x.

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

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Source: dailymed · Ingested: 2026-02-15T12:09:56.238979 · Updated: 2026-03-14T23:14:59.768699