3 ACUTE STRESS- arnica montana, bellis perennis, passiflora incarnata, valeriana officinalis, arsenicum album, apis mellifica, carcinosin, cistus canadensis, clematis erecta, coffea cruda, ignatia amara, lachesis mutus, magnesia phosphorica, natrum muriaticum, natrum sulphuricum, ornithogalum umbellatum, phosphoricum acidum, salix nigra, staphysagria liquid
Biotics Research Corporation

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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Drug Facts:

ACTIVE INGREDIENTS:

Arnica Montana 3X, 30C, Bellis Perennis 3X, 30C, Passiflora Incarnata 3X, 30C, Valeriana Officinalis 3X, 30C, Arsenicum Album 6X, 30C, Apis Mellifica 30C, Carcinosin 30C, Cistus Canadensis 30C, Clematis Erecta 30C, Coffea Cruda 30C, Ignatia Amara 30C, Lachesis Mutus 30C, Magnesia Phosphorica 30C, Natrum Muriaticum 30C, Natrum Sulphuricum 30C, Ornithogalum Umbellatum 30C, Phosphoricum Acidum 30C, Salix Nigra 30C, Staphysagria 30C.

INDICATIONS:

For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

WARNINGS:

If symptoms persist or worsen, seek the advice of a healthcare professional.

Caution: Not recommended for pregnant or lactating women.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

KEEP OUT OF REACH OF CHILDREN
In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional.
Consult a physician for use in children under 6 years of age.

INDICATIONS:

For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.

INACTIVE INGREDIENTS:

Citric Acid, Demineralized Water, Ethanol 1.65%, Sodium Benzoate.

QUESTIONS:

Distributed by

Biotics Research Corporation

Rosenberg, TX 77471 • (281) 344-0909

PACKAGE LABEL DISPLAY:

Biotics Research Corporation's

21ST CENTURY
HOMEOPATHICS
NDC# 55146-003-01

HOMEOPATHIC REMEDY

#3
Acute Stress

Water Based
Formula

4 fl. oz.
(120 ml)

#3 Acute Stress

3 ACUTE STRESS
arnica montana, bellis perennis, passiflora incarnata, valeriana officinalis, arsenicum album, apis mellifica, carcinosin, cistus canadensis, clematis erecta, coffea cruda, ignatia amara, lachesis mutus, magnesia phosphorica, natrum muriaticum, natrum sulphuricum, ornithogalum umbellatum, phosphoricum acidum, salix nigra, staphysagria liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55146-003
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	3 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	3 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_X] in 1 mL
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	30 [hp_C] in 1 mL
HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K)	HUMAN BREAST TUMOR CELL	30 [hp_C] in 1 mL
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3)	HELIANTHEMUM CANADENSE	30 [hp_C] in 1 mL
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	30 [hp_C] in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	30 [hp_C] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	30 [hp_C] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	30 [hp_C] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	30 [hp_C] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C] in 1 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	30 [hp_C] in 1 mL
ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S)	ORNITHOGALUM UMBELLATUM	30 [hp_C] in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN)	PHOSPHORIC ACID	30 [hp_C] in 1 mL
SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3)	SALIX NIGRA BARK	30 [hp_C] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55146-003-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/11/2019

Labeler - Biotics Research Corporation (092487347)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(55146-003) , api manufacture(55146-003) , label(55146-003) , pack(55146-003)