AMOEBASODE- triticum aestivum, cajuputum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, quassia (amara), senna (cassia angustifolia), absinthium, hepar bovine, spleen (bovine), glandula suprarenalis bovine, cinchona officinalis, lycopodium clavatum, amoeba axis, giardia lamblia 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:

TRITICUM AESTIVUM MT, CAJUPUTUM 1X, BAPTISIA TINCTORIA 3X, CAPSICUM ANNUUM 3X, FRASERA CAROLINIENSIS 3X, QUASSIA (AMARA) 3X, SENNA (CASSIA ANGUSTIFOLIA) 3X, ABSINTHIUM 6X, HEPAR BOVINE 8X, 10X, 12X, 24X, SPLEEN (BOVINE) 8X, 10X, 12X, 24X, GLANDULA SUPRARENALIS BOVINE 8X, 12X, 24X, 30X, CINCHONA OFFICINALIS 12X, LYCOPODIUM CLAVATUM 12X, AMOEBA AXIS 8C, 15C, 30C, 100C, GIARDIA LAMBLIA 9C, 15C, 30C, 100C.

INDICATIONS:

For temporary relief of symptoms of diarrhea, mucus in stools, and intestinal bloating.

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 medial 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 symptoms of diarrhea, mucus in stools, and intestinal bloating.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

PACKAGE DISPLAY LABEL:

Synergy Formula

AMOEBASODE

HOMEOPATHIC

2 FL OZ (60 mL)

Amoebasode 2 oz

AMOEBASODE
triticum aestivum, cajuputum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, quassia (amara), senna (cassia angustifolia), absinthium, hepar bovine, spleen (bovine), glandula suprarenalis bovine, cinchona officinalis, lycopodium clavatum, amoeba axis, giardia lamblia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43772-0047
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU)	TRITICUM AESTIVUM WHOLE	1 [hp_X] in 1 mL
CAJUPUT OIL (UNII: J3TO6BUQ37) (CAJUPUT OIL - UNII:J3TO6BUQ37)	CAJUPUT OIL	1 [hp_X] in 1 mL
BAPTISIA TINCTORIA (UNII: 5K1UO2888Y) (BAPTISIA TINCTORIA - UNII:5K1UO2888Y)	BAPTISIA TINCTORIA	3 [hp_X] in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	3 [hp_X] in 1 mL
FRASERA CAROLINIENSIS ROOT (UNII: 1JX35YMF5T) (FRASERA CAROLINIENSIS ROOT - UNII:1JX35YMF5T)	FRASERA CAROLINIENSIS ROOT	3 [hp_X] in 1 mL
QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW)	QUASSIA AMARA WOOD	3 [hp_X] in 1 mL
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	3 [hp_X] in 1 mL
WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV)	WORMWOOD	6 [hp_X] in 1 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	8 [hp_X] in 1 mL
BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3)	BOS TAURUS SPLEEN	8 [hp_X] in 1 mL
BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29)	BOS TAURUS ADRENAL GLAND	8 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	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
AMOEBA PROTEUS (UNII: APR291GFYV) (AMOEBA PROTEUS - UNII:APR291GFYV)	AMOEBA PROTEUS	8 [hp_C] in 1 mL
GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73)	GIARDIA LAMBLIA	9 [hp_C] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43772-0047-1	60 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/21/2015

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43772-0047) , api manufacture(43772-0047) , label(43772-0047) , pack(43772-0047)