TONSILLA COMPOSITUM- conium maculatum flowering top, solanum dulcamara top, echinacea, unspecified, horse chestnut,antimony potassium tartrate, ascorbic acid, protortonia cacti,galium aparine,gentiana lutea root,geranium robertianum, pulsatilla vulgaris,lactic acid, l-, sus scrofa adrenal gland,sulfur,tribasic calcium phosphate,ferrosoferric phosphate,sus scrofa umbilical cord,pork liver,sus scrofa hypothalamussus scrofa bone marrow,sus scrofa spleen,sus scrofa adrenal gland, cortisone acetate, sus scrofa embryo, solution
Medinatura 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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Tonsilla compositum oral vial

DESCRIPTION

Each 2.2 ml ampule contains:

Ingredient Name	Potency	Quantity
Conium maculatum	4x	22µ
Dulcamara	4x	22µ
Echinacea	4x	22µ
Aesculus hippocastanum	6x	22µ
Antimonium tartaricum	10x	22µ
Ascorbicum acidum	6x	22µ
Coccus cacti	4x	22µ
Galium aparine	6x	22µ
Gentiana lutea	8x	22µ
Geraniumrobertianum	6x	22µ
Pulsatilla	8x	22µ
Sarcolacticum acidum	6x	22µ
Glandula lymphatica	8x	22µ
Sulphur	8x	22µ
Calcarea phosphorica	10x	22µ
Ferrum phosphoricum	10x	22µ
Funiculus umbilicalis suis	10x	22µ
Hepar suis	10x	22µ
Hypothalamus suis	10x	22µ
Medulla ossis suis	10x	22µ
Splen suis	10x	22µ
Cortisone aceticum	13x	22µ
Embryo suis	13x	22µ
Mercurius solubilis	13x	22µ
Levothyroxinue	13x	22µ
Baryta carbonica	28x	22µ
Tonsilla suis

Inactive Ingredient: Isotonic Sodium Chloride solution

INDICATION AND USAGE

Tonsilla compositum® Oral Vial is a homeopathic drug product indicated for the temporary relief of minor throat, laryngitis and minor throat irritation.

DOSAGE AND ADMINISTRATION

Dosage:

Adults and children above 6 years: 1 vial orally 1-3 times daily

Children up to 6 years: ½ vial orally 1-3 times daily

CONTRAINDICATIONS

Tonsilla compositum® Oral Vials are contraindicated in patients with known hypersensitivity to Tonsilla compositum® or any of its ingredients.

WARNINGS AND PRECAUTIONS

Warnings and Precautions

None

ADVERSE REACTIONS

No adverse events have been reported with a causal relationship Thonsilla compositum® Oral Vials.

OVERDOSAGE

Overdosage: No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions

CLINICAL PHARMACOLOGY

Mechanism of Action The exact mechanism of Tonsilla compositum® Oral Vials is not fully understood. Pharmacodynamics Not applicable for homeopathic medicinal products.

DOSAGE

1 oral vial containing 2.2ml solution for oral administration

Tonsilla compositum oral vial.jpg

TONSILLA COMPOSITUM
conium maculatum flowering top, solanum dulcamara top, echinacea, unspecified, horse chestnut,antimony potassium tartrate, ascorbic acid, protortonia cacti,galium aparine,gentiana lutea root,geranium robertianum, pulsatilla vulgaris,lactic acid, l-, sus scrofa adrenal gland,sulfur,tribasic calcium phosphate,ferrosoferric phosphate,sus scrofa umbilical cord,pork liver,sus scrofa hypothalamussus scrofa bone marrow,sus scrofa spleen,sus scrofa adrenal gland, cortisone acetate, sus scrofa embryo, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:50114-0104
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	4 [hp_X] in 2.2 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N)	SOLANUM DULCAMARA TOP	4 [hp_X] in 2.2 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	4 [hp_X] in 2.2 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	6 [hp_X] in 2.2 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	6 [hp_X] in 2.2 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	6 [hp_X] in 2.2 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	6 [hp_X] in 2.2 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488)	GALIUM APARINE	6 [hp_X] in 2.2 mL
GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS)	GENTIANA LUTEA ROOT	6 [hp_X] in 2.2 mL
GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) (GERANIUM ROBERTIANUM - UNII:R5I1HK0UBL)	GERANIUM ROBERTIANUM	6 [hp_X] in 2.2 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X] in 2.2 mL
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N)	LACTIC ACID, L-	6 [hp_X] in 2.2 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 [hp_X] in 2.2 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	10 in 2.2 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	10 [hp_X] in 2.2 mL
SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H)	SUS SCROFA UMBILICAL CORD	10 [hp_X] in 2.2 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F)	PORK LIVER	10 [hp_X] in 2.2 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	10 [hp_X] in 2.2 mL
SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8)	SUS SCROFA BONE MARROW	10 [hp_X] in 2.2 mL
SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y)	SUS SCROFA SPLEEN	10 [hp_X] in 2.2 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	13 [hp_X] in 2.2 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ)	CORTISONE ACETATE	13 [hp_X] in 2.2 mL
SUS SCROFA EMBRYO (UNII: 9928MC12VO) (SUS SCROFA EMBRYO - UNII:9928MC12VO)	SUS SCROFA EMBRYO	13 [hp_X] in 2.2 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	13 [hp_X] in 2.2 mL
LEVOTHYROXINE (UNII: Q51BO43MG4) (LEVOTHYROXINE - UNII:Q51BO43MG4)	LEVOTHYROXINE	13 [hp_X] in 2.2 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	28 [hp_X] in 2.2 mL
SUS SCROFA TONSIL (UNII: TB08NIC03W) (SUS SCROFA TONSIL - UNII:TB08NIC03W)	SUS SCROFA TONSIL	28 [hp_X] in 2.2 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-0104-6	10 in 1 CARTON	01/31/1993	09/30/2014
1		2.2 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/1993	09/30/2014

Labeler - Medinatura Inc (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
Medinatura Inc		102783016	manufacture(50114-0104)

Revised: 1/2017

Document Id: 9dddd916-6057-4b69-ba6f-dda33ee65614

Set id: a38832a4-f8e6-491d-89ec-a770835bce14

Version: 2

Effective Time: 20170125

Medinatura Inc