DRUG FACTS:

Drug Labeling and Warnings

Drug Details [pdf]

LYME HP- baptisia tinctoria, echinacea, hydrastis canadensis, lym d nosode, arsenicum album, bryonia, chelidonium majus, colchicum autumnale, kalmia latifolia, ledum palustre, lycopodium clavatum, phosphorus, rhus tox liquid 
Energique, 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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DRUG FACTS:

ACTIVE INGREDIENTS:

BAPTISIA TINCTORIA 3X,  ECHINACEA (ANGUSTIFOLIA) 3X,  HYDRASTIS CANADENSIS 3X,  BORRELIA BURGDORFERI 12X, 30X, 200X,  ENCEPHALITIS NOSODE 12X, 30X, 200X,  HEPATITIS B NOSODE 12X, 30X, 200X, MENINGOCOCCUS NOSODE 12X, 30X, 200X,  ARSENICUM ALBUM 30C,  BRYONIA (ALBA) 30C,  CHELIDONIUM MAJUS 30C,  COLCHICUM AUTUMNALE 30C,  KALMIA LATIFOLIA 30C,  LEDUM PALUSTRE 30C,  LYCOPODIUM CLAVATUM 30C,  PHOSPHORUS 30C,  RHUS TOXICODENDRON 30C

INDICATIONS:

For temporary relief of aches and pains of joints and muscles as a consequence of Lyme Disease infection.**

**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, 3 times 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 aches and pains of joints and muscles as a consequence of Lyme Disease infection.**

**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

888.869.8078

*For a complete list of Lyme Nosode contact Energique, Inc.

PACKAGE LABEL DISPLAY:

ENERGIQUE

HOMEOPATHIC REMEDY

LYME HP

1 fl oz. (30 ml) 20% Ethanol

LYME  HP
baptisia tinctoria, echinacea, hydrastis canadensis, lym d nosode, arsenicum album, bryonia, chelidonium majus, colchicum autumnale, kalmia latifolia, ledum palustre, lycopodium clavatum, phosphorus, rhus tox liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44911-0114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8)	BORRELIA BURGDORFERI	12 [hp_X]  in 1 mL
JAPANESE ENCEPHALITIS VIRUS (UNII: P07E7XWU9D) (JAPANESE ENCEPHALITIS VIRUS - UNII:P07E7XWU9D)	JAPANESE ENCEPHALITIS VIRUS	12 [hp_X]  in 1 mL
HEPATITIS B VIRUS (UNII: 77H9EM77P7) (HEPATITIS B VIRUS - UNII:77H9EM77P7)	HEPATITIS B VIRUS	12 [hp_X]  in 1 mL
NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (NEISSERIA MENINGITIDIS - UNII:V3TP2MD7F3)	NEISSERIA MENINGITIDIS	12 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	30 [hp_C]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	30 [hp_C]  in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	30 [hp_C]  in 1 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6)	COLCHICUM AUTUMNALE BULB	30 [hp_C]  in 1 mL
KALMIA LATIFOLIA LEAF (UNII: 79N6542N18) (KALMIA LATIFOLIA LEAF - UNII:79N6542N18)	KALMIA LATIFOLIA LEAF	30 [hp_C]  in 1 mL
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_C]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_C]  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: 44911-0114-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/20/2014	10/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/20/2014	10/30/2019

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(44911-0114) , api manufacture(44911-0114) , label(44911-0114) , pack(44911-0114)

Revised: 12/2018

Document Id: 5c6897c6-ead4-4dfe-9d43-252134b58670

34390-5

Set id: a8ae8a0f-e0be-477b-9b2f-56ba2d1e962f

Version: 2

Effective Time: 20181220