CALCIUM COMPOSITION- arnica montana, echinacea (angustifolia), boron glucconate, symphytum officinale, hekla lava, calcarea carbonica, clacarea fluorica, calcarea phosphorica, lycopodium clavatum, silicea. 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:

Arnica Montana 3X, Echinacea (Angustifolia) 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.

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:

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

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:

SYNERGY FORMULAS, INC

251 West Road

Campobello, SC 29322

PACKAGE LABEL DISPLAY:

Synergy Formulas

CALCIUM COMPOSITION

HOMEOPATHIC

2 FL OZ (60 ml)

Calcium Composition

CALCIUM COMPOSITION 
arnica montana, echinacea (angustifolia), boron glucconate, symphytum officinale, hekla lava, calcarea carbonica, clacarea fluorica, calcarea phosphorica, lycopodium clavatum, silicea. liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43772-0037
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
BORON GLUCONATE (UNII: X8P2SY4Y7V) (BORON - UNII:N9E3X5056Q) BORON GLUCONATE6 [hp_X]  in 1 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 1 mL
HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA8 [hp_X]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43772-0037-160 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/16/2014
Labeler - Synergy Formulas, Inc (069579220)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43772-0037) , api manufacture(43772-0037) , label(43772-0037) , pack(43772-0037)

Revised: 7/2014
Document Id: 1714ac26-b447-45a7-a43d-b24f789f3963
Set id: cdf4b153-3c92-4e3e-b3ac-f41153fc3941
Version: 1
Effective Time: 20140716
 
Synergy Formulas, Inc