Calcium Composition (Arnica Montana, Echinacea, Boron Gluconate, Symphytum Officinale, Hekla Lava, Calcarea Carbonica) Liquid [Synergy Formulas, Inc.] -

CALCIUM COMPOSITION (ARNICA MONTANA, ECHINACEA, BORON GLUCONATE, SYMPHYTUM OFFICINALE, HEKLA LAVA, CALCAREA CARBONICA) LIQUID [SYNERGY FORMULAS, INC.]
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NDC	43772-0009-1
Set ID	436f03cb-f2d1-4ab7-b747-7cb1a38b8a6a
Category	HUMAN OTC DRUG LABEL
Packager	Synergy Formulas, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS

Arnica Montana 3X, Echinacea 3X, Boron Gluconate 6X, 12X, Symphytum Officinale 6X, 30X, Hekla Lava 8X, 30X, Calcarea Carbonica 12X, 30X, Calcarea Fluorica 12X, 30X, Calcarea Phosphorica 12X, 30X, Lycopodium Clavatum 12X, 30X, Silicea 12X, 30X, 200X
INDICATIONS

Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.
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.
DIRECTIONS

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

Demineralized Water, 25% Ethanol
KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.
INDICATIONS AND USAGE

Provides temporary relief of tickling cough, troublesome at night. Pains in the joints, and bones. Cramps in calves and soles of feet.
QUESTIONS

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322
PRINCIPAL DISPLAY PANEL

Synergy Formulas

CALCIUM COMPOSITION

HOMEOPATHIC

2 FL OZ (60 ml)

INGREDIENTS AND APPEARANCE

CALCIUM COMPOSITION
arnica montana, echinacea, boron gluconate, symphytum officinale, hekla lava, calcarea carbonica liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43772-0009
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X] in 1 mL
BORON GLUCONATE (UNII: X8P2SY4Y7V) (BORON - UNII:N9E3X5056Q)	BORON GLUCONATE	6 [hp_X] in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X] in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK)	HEKLA LAVA	8 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X] in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	12 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	TRIBASIC CALCIUM PHOSPHATE	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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X] 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:43772-0009-1	60 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/02/2013

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43772-0009)

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Medic

CALCIUM COMPOSITION (ARNICA MONTANA, ECHINACEA, BORON GLUCONATE, SYMPHYTUM OFFICINALE, HEKLA LAVA, CALCAREA CARBONICA) LIQUID [SYNERGY FORMULAS, INC.]

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