HBP: Package Insert and Label Information

HBP- micrurus corallinus venom, viscum album fruiting top, ruta graveolens flowering top, vipera berus venom, epinephrine, arsenic triiodide, gold, barium carbonate, bryonia alba root, selenicereus grandiflorus stem, chelidonium majus, cinchona officinalis bark, crotalus horridus horridus venom, digitalis, nitroglycerin, potassium carbonate, potassium iodide, lachesis muta venom, naja naja venom, strychnos nux-vomica seed, veratrum album root and valerian liquid
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as headache, ear ringing, anxiety, sweating, pallor and nausea.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC — ACTIVE INGREDIENT SECTION

Equal parts of Ruta graveolens 6x, Valeriana officinalis 6x, Adrenalinum 15x, Arsenicum iodatum 15x, Aurum metallicum 15x, Baryta carbonica 15x, Bryonia 15x, Cactus grandiflorus 15x, Chelidonium majus 15x, Cinchona officinalis 15x, Crotalus horridus 15x, Digitalis purpurea 15x, Glonoinum 15x, Kali carbonicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Naja tripudians 15x, Nux vomica 15x, Veratrum album 15x, Vipera berus 15x, Viscum album 15x, Elaps corallinus 30x.

OTC — PURPOSE SECTION

Formulated for associated symptoms such as headache, ear ringing, anxiety, sweating, pallor and nausea.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

HBP ruta graveolens, valeriana officinalis, adrenalinum, arsenicum iodatum, aurum metallicum, baryta carbonica, bryonia, cactus grandiflorus, chelidonium majus, cinchona officinalis, crotalus horridus, digitalis purpurea, glonoinum, kali carbonicum, kali iodatum, lachesis mutus, naja tripudians, nux vomica, veratrum album, vipera berus, viscum album, elaps corallinus. liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4841 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICRURUS CORALLINUS VENOM (MICRURUS CORALLINUS VENOM) MICRURUS CORALLINUS VENOM 30 [hp_X] in 1 mL VISCUM ALBUM FRUITING TOP (VISCUM ALBUM FRUITING TOP) VISCUM ALBUM FRUITING TOP 15 [hp_X] in 1 mL RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X] in 1 mL VIPERA BERUS VENOM (VIPERA BERUS VENOM) VIPERA BERUS VENOM 15 [hp_X] in 1 mL EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 15 [hp_X] in 1 mL ARSENIC TRIIODIDE (ARSENIC CATION (3+)) ARSENIC TRIIODIDE 15 [hp_X] in 1 mL GOLD (GOLD) GOLD 15 [hp_X] in 1 mL BARIUM CARBONATE (BARIUM CATION) BARIUM CARBONATE 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL SELENICEREUS GRANDIFLORUS STEM (SELENICEREUS GRANDIFLORUS STEM) SELENICEREUS GRANDIFLORUS STEM 15 [hp_X] in 1 mL CHELIDONIUM MAJUS (CHELIDONIUM MAJUS) CHELIDONIUM MAJUS 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL CROTALUS HORRIDUS HORRIDUS VENOM (CROTALUS HORRIDUS HORRIDUS VENOM) CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X] in 1 mL DIGITALIS (DIGITALIS) DIGITALIS 15 [hp_X] in 1 mL NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 15 [hp_X] in 1 mL POTASSIUM CARBONATE (CARBONATE ION) POTASSIUM CARBONATE 15 [hp_X] in 1 mL POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 15 [hp_X] in 1 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 15 [hp_X] in 1 mL NAJA NAJA VENOM (NAJA NAJA VENOM) NAJA NAJA VENOM 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL VERATRUM ALBUM ROOT (VERATRUM ALBUM ROOT) VERATRUM ALBUM ROOT 15 [hp_X] in 1 mL VALERIAN (VALERIAN) VALERIAN 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-4841-1 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2020

Labeler — Newton Laboratories, Inc. (788793610)

Registrant — Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Operations
Newton Laboratories, Inc.		788793610	manufacture (55714-4841)

Revised: 05/2020 Newton Laboratories, Inc.