STAGE FRIGHT-FEAR- passiflora incarnata, valeriana officinalis, aconitum napellus, anacardium orientale, argentum nitricum, arsenicum album, cypripedium pubescens, gelsemium sempervirens, ignatia amara, kali carbonicum, lycopodium clavatum, natrum muriaticum, phosphorus, sambucus nigra, sepia, staphysagria, stramonium, tarentula hispana, theridion 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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Stage 2522L

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Anacardium orientale 15x, Argentum nitricum 15x, Arsenicum album 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali carbonicum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Sambucus nigra 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Tarentula hispana 15x, Theridion 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with performance anxiety such as apprehension, nausea, restlessness, trembling and over-sensitivity.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as need or as directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

PACKAGE LABEL

package label

STAGE FRIGHT-FEAR
passiflora incarnata, valeriana officinalis, aconitum napellus, anacardium orientale, argentum nitricum, arsenicum album, cypripedium pubescens, gelsemium sempervirens, ignatia amara, kali carbonicum, lycopodium clavatum, natrum muriaticum, phosphorus, sambucus nigra, sepia, staphysagria, stramonium, tarentula hispana, theridion liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2522
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X] in 1 mL
SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU)	SEMECARPUS ANACARDIUM JUICE	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
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
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	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
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	15 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	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
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT)	LYCOSA TARANTULA	15 [hp_X] in 1 mL
THERIDION CURASSAVICUM (UNII: 9Z8D3HEM8L) (THERIDION CURASSAVICUM - UNII:9Z8D3HEM8L)	THERIDION CURASSAVICUM	15 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X] in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [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:55714-2522-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2019

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

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2522)