LYMESODE- echinacea (angustifolia), hydrastis canadensis, lycopodium clavatum, nasturtium aquaticum, taraxacum officinale, trifolium pratense, rhus tox, arnica montana, glandula suprarenalis suis, medulla ossis suis, thymus (suis), oxalicum acidum, magnesia phosphorica, latrodectus mactans, borrelia burgdorferi nosode, encephalitis nosode, meningococcus nosode, hepatitis b nosode liquid 
Synergy Formulas, 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:

Echinacea (Angustifolia) 3X, Hydrastis Canadensis 3X, Lycopodium Clavatum 3X, Nasturtium Aquaticum 3X, Taraxacum Officinale 3X, Trifolium Pratense 3X, Rhus Tox 5X, 12X, Arnica Montana 6X, Glandula Suprarenalis Suis 6X, Medulla Ossis Suis 6X, Thymus (Suis) 6X, Oxalicum Acidum 6X, 12X, Magnesia Phosphorica 8X, Latrodectus Mactans 8X, 12X, Borrelia Burgdorferi Nosode 12X, 30X, 200X, Encephalitis Nosode 12X, 30X, 200X, Meningococcus Nosode 15X, 30X, 200X, Hepatitis B Nosode 30X, 200X.

INDICATIONS:

For temporary relief of aches, pains and fatigue associated with Lyme disease.

WARNINGS:

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

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

Do not use if tamper evident seal is broken or missing.

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:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of aches, pains and fatigue associated with Lyme disease.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

PACKAGE LABEL DISPLAY:

Synergy Formulas

LYMESODE

HOMEOPATHIC

2 FL OZ (60 ml)

Lymesode

LYMESODE 
echinacea (angustifolia), hydrastis canadensis, lycopodium clavatum, nasturtium aquaticum, taraxacum officinale, trifolium pratense, rhus tox, arnica montana, glandula suprarenalis suis, medulla ossis suis, thymus (suis), oxalicum acidum, magnesia phosphorica, latrodectus mactans, borrelia burgdorferi nosode, encephalitis nosode, meningococcus nosode, hepatitis b nosode liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0038
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE3 [hp_X]  in 1 mL
NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM AQUATICUM - UNII:YH89GMV676) NASTURTIUM OFFICINALE3 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE3 [hp_X]  in 1 mL
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER3 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF3 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]  in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND6 [hp_X]  in 1 mL
SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW6 [hp_X]  in 1 mL
SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS6 [hp_X]  in 1 mL
OXALIC ACID (UNII: 9E7R5L6H31) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID6 [hp_X]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 1 mL
LATRODECTUS MACTANS (UNII: XJJ7QA858R) (LATRODECTUS MACTANS - UNII:XJJ7QA858R) LATRODECTUS MACTANS8 [hp_X]  in 1 mL
BORRELIA BURGDORFERI (UNII: 0J8NV9V5Q8) (BORRELIA BURGDORFERI - UNII:0J8NV9V5Q8) BORRELIA BURGDORFERI12 [hp_X]  in 1 mL
JAPANESE ENCEPHALITIS VIRUS (UNII: P07E7XWU9D) (JAPANESE ENCEPHALITIS VIRUS - UNII:P07E7XWU9D) JAPANESE ENCEPHALITIS VIRUS12 [hp_X]  in 1 mL
NEISSERIA MENINGITIDIS (UNII: V3TP2MD7F3) (NEISSERIA MENINGITIDIS - UNII:V3TP2MD7F3) NEISSERIA MENINGITIDIS15 [hp_X]  in 1 mL
HEPATITIS B VIRUS (UNII: 77H9EM77P7) (HEPATITIS B VIRUS - UNII:77H9EM77P7) HEPATITIS B VIRUS30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43772-0038-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/15/2014
Labeler - Synergy Formulas, Inc. (069579220)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43772-0038) , api manufacture(43772-0038) , label(43772-0038) , pack(43772-0038)

Revised: 7/2014
Document Id: 4b58c4de-2677-4791-ac10-a3119fe7923b
Set id: 09c53a0d-c655-40f6-9419-d27b17e2989d
Version: 1
Effective Time: 20140715
 
Synergy Formulas, Inc.