SYSTEMISTAT- berberis vulgaris, chelidonium majus, hydrastis canadensis, lappa major, hepar sulphuris calcareum, lycopodium clavatum, sulphur, calcarea carbonica, mercurius solubilis, thuja occidentalis liquid

Systemistat by

Drug Labeling and Warnings

Systemistat by is a Homeopathic medication manufactured, distributed, or labeled by Energique, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Berberis Vulgaris 3X, Chelidonium Majus 3X, Hydrastis Canadensis 3X, Lappa Major 3X, Hepar Sulphuris Calcareum 12X, Lycopodium Clavatum 12X, Sulphur 12X, Calcarea Carbonica 30X, Mercurius Solubilis 30X, Thuja Occidentalis 30X.

INDICATIONS:

For temporary relief of painless, clay colored diarrhea, eczema with itching, burning hay fever with offensive discharge running from the nose.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

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

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

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:

Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of painless, clay colored diarrhea, eczema with itching, burning hay fever with offensive discharge running from the nose.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.

QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

SYSTEMISTAT

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

SYSTEMISTAT 
berberis vulgaris, chelidonium majus, hydrastis canadensis, lappa major, hepar sulphuris calcareum, lycopodium clavatum, sulphur, calcarea carbonica, mercurius solubilis, thuja occidentalis liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0281
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	3 [hp_X]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 mL
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3)	ARCTIUM LAPPA ROOT	3 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	30 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	30 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44911-0281-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/23/2015	11/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/23/2015	11/10/2020

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0281) , api manufacture(44911-0281) , label(44911-0281) , pack(44911-0281)