HYPERCALM-MENTAL FOCUS- chamomilla, echinacea, hypericum perforatum, passiflora incarnata, aconitum napellus, adrenalinum, argentum nit., arsenicum album, baptisia tinctoria, chamomilla, coffea cruda, cypripedium pubescens, digitalis purpurea, gelsemium sempervirens, humulus lupulus, hyoscyamus niger, ignatia amara, impatiens glandulifera flos, iodium, lachesis mutus, lycopodium clavatum, natrum muriaticum, nux vomica, scutellaria lateriflora, staphysagria, stramonium, tarentula cubensis, theridion, veratrum viride 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.

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Hypercalm 1535L-Disc

INDICATIONS AND USAGE SECTION

Formulated for associated symptoms such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.

DOSAGE & ADMINISTRATION SECTION

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) one to four times daily or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Chamomilla 6x, Echinacea 6x, Hypericum perforatum 6x, Passiflora incarnata 6x, Aconitum napellus 15x, Adrenalinum 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Chamomilla 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Digitalis purpurea 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Hyoscyamus niger 15x, Ignatia amara 15x, Impatiens glandulifera flos 15x, Iodium 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Nux vomica 15x, Scutellaria lateriflora 15x, Staphysagria 15x, Stramonium 15x, Tarentula cubensis 15x, Theridion 15x, Veratrum viride 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.

INACTIVE INGREDIENT SECTION

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

WARNINGS: Keep out of reach of children.

PACKAGE LABEL

package label

HYPERCALM-MENTAL FOCUS
chamomilla, echinacea, hypericum perforatum, passiflora incarnata, aconitum napellus, adrenalinum, argentum nit., arsenicum album, baptisia tinctoria, chamomilla, coffea cruda, cypripedium pubescens, digitalis purpurea, gelsemium sempervirens, humulus lupulus, hyoscyamus niger, ignatia amara, impatiens glandulifera flos, iodium, lachesis mutus, lycopodium clavatum, natrum muriaticum, nux vomica, scutellaria lateriflora, staphysagria, stramonium, tarentula cubensis, theridion, veratrum viride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-1535
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	15 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X] in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X] in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	15 [hp_X] in 1 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	15 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	15 [hp_X] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	15 [hp_X] in 1 mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	15 [hp_X] in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	15 [hp_X] in 1 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	15 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	15 [hp_X] in 1 mL
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	15 [hp_X] in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	15 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X] in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	15 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 mL
SCUTELLARIA LATERIFLORA WHOLE (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA WHOLE - UNII:7BP4DH5PDC)	SCUTELLARIA LATERIFLORA WHOLE	15 [hp_X] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	15 [hp_X] in 1 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	15 [hp_X] in 1 mL
CITHARACANTHUS SPINICRUS (UNII: 3Y5X6RT823) (CITHARACANTHUS SPINICRUS - UNII:3Y5X6RT823)	CITHARACANTHUS SPINICRUS	15 [hp_X] in 1 mL
THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L)	THERIDION CURASSAVICUM	15 [hp_X] in 1 mL
VERATRUM VIRIDE ROOT (UNII: 197B3Q7T5Q) (VERATRUM VIRIDE ROOT - UNII:197B3Q7T5Q)	VERATRUM VIRIDE ROOT	15 [hp_X] in 1 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	15 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-1535-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2019	11/27/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2019	11/27/2023

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-1535)

Revised: 11/2023

Document Id: 0b273fa2-07e6-fc40-e063-6294a90a474c

Set id: 9daf0c9b-fbf1-08f4-e053-2a95a90a481d

Version: 2

Effective Time: 20231127

Newton Laboratories, Inc.