Exhaustion: Homeopathic Product Information

EXHAUSTION- aconitum napellus, epinephrine, american ginseng, arnica montana, arsenic trioxide, baptisia tinctoria, bryonia alba root, lytta vesicatoria, chelidonium majus, cinchona officinalis bark, iodine, potassium carbonate, potassium iodide, lachesis muta venom, lycopodium clavatum spore, lycopus virginicus, sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, toxicodendron pubescens leaf, saw palmetto, thyroid, unspecified, echinacea, unspecified, ginkgo and phytolacca americana root 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 symptoms of mental and physical exhaustion, lack of concentration and apathy.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouthy (ages 6 to 11, give 3 drops) as needed or as directed by a health professional.

OTC — ACTIVE INGREDIENT SECTION

Active Ingredients: Equal parts of Echinacea 11x, Gingko biloba 11x, Phytolacca decandra 11x, Aconitum napellus 20x, Adrenalinum 20x, Aralia quinquefolia 20x, Arnica montana 20x, Arsenicum album 20x, Baptisia tinctoria 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Cinchona officinalis 20x, Iodium 20x, Kali carbonicum 20x, Kali iodatum 20x, Lachesis mutus 20x, Lycopodium clavatum 20x, Lycopus virginicus 20x, Natrum muriaticum 20x, Nux vomica 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabal serrulata 20x, Thyroidinum 20x.

OTC — PURPOSE SECTION

Formulated for symptoms such as mental and physical exhaustion, lack of concentration and apathy.

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.

EXHAUSTION aconitum nap., adrenalinum, aralia quinquefolia, arnica, arsenicum alb., baptisia, bryonia, cantharis, chelidonium majus, cinchona, iodium, kali carb., kali iod., lachesis, lycopodium, lycopus virginicus, nat. mur., nux vom., phosphorus, pulsatilla, rhus toxicodendron, sabal, thyroidinum, echinacea, gingko, phytolacca. liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4814 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 20 [hp_X] in 1 mL EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 20 [hp_X] in 1 mL AMERICAN GINSENG (AMERICAN GINSENG) AMERICAN GINSENG 20 [hp_X] in 1 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 20 [hp_X] in 1 mL ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 20 [hp_X] in 1 mL BAPTISIA TINCTORIA (BAPTISIA TINCTORIA) BAPTISIA TINCTORIA 20 [hp_X] in 1 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 20 [hp_X] in 1 mL LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA 20 [hp_X] in 1 mL CHELIDONIUM MAJUS (CHELIDONIUM MAJUS) CHELIDONIUM MAJUS 20 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 20 [hp_X] in 1 mL IODINE (IODINE) IODINE 20 [hp_X] in 1 mL POTASSIUM CARBONATE (CARBONATE ION) POTASSIUM CARBONATE 20 [hp_X] in 1 mL POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 20 [hp_X] in 1 mL LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 20 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 20 [hp_X] in 1 mL LYCOPUS VIRGINICUS (LYCOPUS VIRGINICUS) LYCOPUS VIRGINICUS 20 [hp_X] in 1 mL SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 20 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 20 [hp_X] in 1 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 20 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 20 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 20 [hp_X] in 1 mL SAW PALMETTO (SAW PALMETTO) SAW PALMETTO 20 [hp_X] in 1 mL THYROID, UNSPECIFIED (THYROID, UNSPECIFIED) THYROID, UNSPECIFIED 20 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED 11 [hp_X] in 1 mL GINKGO (GINKGO) GINKGO 11 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 11 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-4814-1 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019

Labeler — Newton Laboratories, Inc. (788793610)

Registrant — Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Operations
Newton Laboratories, Inc.		788793610	manufacture (55714-4814)

Revised: 12/2020 Newton Laboratories, Inc.