5 Chronic Stress (Aralia Quinquefolia, Fucus Vesiculosus, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Hydrastis Canadensis, Arsenicum Album, Calcarea Carbonica, Carbo Vegeta -

5 CHRONIC STRESS (ARALIA QUINQUEFOLIA, FUCUS VESICULOSUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, CALCAREA CARBONICA, CARBO VEGETA
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NDC	55146-005-01
Set ID	6f79905b-767b-49d0-8630-7b5348f87e4d
Category	HUMAN OTC DRUG LABEL
Packager	Biotics Research Corporation
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

Aralia Quinquefolia 3X, 30C, Fucus Vesiculosus 3X, 30C, Solidago Virgaurea 3X, 30C, Taraxacum Officinale 3X, 30C, Trifolium Pratense 3X, 30C, Hydrastis Canadensis 5X, 30C, Arsenicum Album 30C, Calcarea Carbonica 30C, Carbo Vegetabilis 30C, Ceanothus Americanus 30C, Cyclamen Europaeum 30C, Hepar Sulphuris Calcareum 30C, Natrum Muriaticum 30C, Nux Vomica 30C, Petroleum30C, Phosphorus 30C.
INDICATIONS:

For temporary relief of debility or exhaustion after slight exertion, or exhaustion following dysentery. Remedy #5 supports the easing of chronic stress produced by natural substances called adaptogens.
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 with an imprinted safety seal for your protection. 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 debility or exhaustion after slight exertion, or exhaustion following dysentery. Remedy #5 supports the easing of chronic stress produced by natural substances called adaptogens.
INACTIVE INGREDIENTS:

Citric acid, Demineralized water, Ethanol, 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 #55146-005-01

HOMEOPATHIC REMEDY

#5

Chronic Stress

Water Based

Formula

(2.85% Ethanol)

4 fl. oz. (120ml)

INGREDIENTS AND APPEARANCE

5 CHRONIC STRESS
aralia quinquefolia, fucus vesiculosus, solidago virgaurea, taraxacum officinale, trifolium pratense, hydrastis canadensis, arsenicum album, calcarea carbonica, carbo vegetabilis, ceanothus americanus, cyclamen europaeum, hepar sulphuris calcareum, natrum muriaticum, nux vomica, petroleum, phosphorus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55146-005
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	3 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	3 [hp_X] in 1 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	3 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	3 [hp_X] in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828)	TRIFOLIUM PRATENSE FLOWER	3 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30 [hp_C] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	30 [hp_C] in 1 mL
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	30 [hp_C] in 1 mL
CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q)	CYCLAMEN PURPURASCENS TUBER	30 [hp_C] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_C] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C] in 1 mL
KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E)	KEROSENE	30 [hp_C] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_C] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55146-005-01	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(55146-005) , api manufacture(55146-005) , label(55146-005) , pack(55146-005)

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Medic

5 CHRONIC STRESS (ARALIA QUINQUEFOLIA, FUCUS VESICULOSUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, CALCAREA CARBONICA, CARBO VEGETA

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