Just 2561l

Just 2561l
SPL v2
SPL
SPL Set ID a035f2bf-2f5d-0a50-e053-2995a90a8d9c
Route
ORAL
Published
Effective Date 2020-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (10 [hp_X]) Echinacea, Unspecified (15 [hp_X]) Rhododendron Tomentosum Leafy Twig (30 [hp_X]) Arsenic Cation (3+) Agkistrodon Contortrix Venom Crotalus Durissus Terrificus Venom Crotalus Horridus Horridus Venom Aconitum Napellus Mercuric Cation Naja Naja Venom Phosphorus Agkistrodon Piscivorus Venom Vipera Berus Venom Micrurus Corallinus Venom Heloderma Horridum Venom Arnica Montana Lachesis Muta Venom
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-03-02
Description

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Purpose

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Medication Information

Purpose

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Description

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

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 symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

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. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: For use as an interim therapy. Seek professional medical intervention for severe injuries, bites or infections.

Otc Active Ingredient Section

Equal parts of Aconitum napellus 10x, Arnica montana 10x, Bryonia 10x, Echinacea 10x, Ledum palustre 10x, Arsenicum album 15x, Cenchris contortrix 15x, Crotalus cascavella 15x, Crotalus horridus 15x, Lachesis mutus 15x, Mercurius corrosivus 15x, Naja tripudians 15x, Phosphorus 15x, Toxicophis pugnax 15x, Vipera berus 15x, Elaps corallinus 30x, Heloderma 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 symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for symptoms associated with wilderness injuries, infections and bites such as restlessness, bleeding, trembling, nausea, vomiting, swelling, pain and confusion.

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. Sensitive persons begin with 1 drop and gradually increase to full dose. Warning: For use as an interim therapy. Seek professional medical intervention for severe injuries, bites or infections.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Aconitum napellus 10x, Arnica montana 10x, Bryonia 10x, Echinacea 10x, Ledum palustre 10x, Arsenicum album 15x, Cenchris contortrix 15x, Crotalus cascavella 15x, Crotalus horridus 15x, Lachesis mutus 15x, Mercurius corrosivus 15x, Naja tripudians 15x, Phosphorus 15x, Toxicophis pugnax 15x, Vipera berus 15x, Elaps corallinus 30x, Heloderma 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

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Source: dailymed · Ingested: 2026-02-15T12:11:57.763770 · Updated: 2026-03-14T23:17:16.187940