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Tonsilla compositum

Heel Inc

Tonsilla compositum oral vial


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

TONSILLA COMPOSITUM 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

Geranium robertianum

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.

TONSILLA COMPOSITUM 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

TONSILLA COMPOSITUM 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

TONSILLA COMPOSITUM 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 Tonsilla compositum

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 label Item Code (Source) NDC:50114-0104
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 4 [hp_X]
Solanum Dulcamara Top Solanum Dulcamara Top 4 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 4 [hp_X]
HORSE CHESTNUT HORSE CHESTNUT 6 [hp_X]
Antimony Potassium Tartrate ANTIMONY CATION (3+) 6 [hp_X]
ASCORBIC ACID ASCORBIC ACID 6 [hp_X]
PROTORTONIA CACTI PROTORTONIA CACTI 6 [hp_X]
GALIUM APARINE GALIUM APARINE 6 [hp_X]
GENTIANA LUTEA ROOT GENTIANA LUTEA ROOT 6 [hp_X]
GERANIUM ROBERTIANUM GERANIUM ROBERTIANUM 6 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 6 [hp_X]
LACTIC ACID, L- LACTIC ACID, L- 6 [hp_X]
SULFUR SULFUR 8 [hp_X]
TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION 10 1
FERROSOFERRIC PHOSPHATE Ferrosoferric Phosphate 10 [hp_X]
SUS SCROFA UMBILICAL CORD SUS SCROFA UMBILICAL CORD 10 [hp_X]
PORK LIVER PORK LIVER 10 [hp_X]
SUS SCROFA HYPOTHALAMUS SUS SCROFA HYPOTHALAMUS 10 [hp_X]
SUS SCROFA BONE MARROW SUS SCROFA BONE MARROW 10 [hp_X]
SUS SCROFA SPLEEN SUS SCROFA SPLEEN 10 [hp_X]
SUS SCROFA ADRENAL GLAND SUS SCROFA ADRENAL GLAND 13 [hp_X]
CORTISONE ACETATE CORTISONE 13 [hp_X]
SUS SCROFA EMBRYO SUS SCROFA EMBRYO 13 [hp_X]
MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS 13 [hp_X]
LEVOTHYROXINE LEVOTHYROXINE 13 [hp_X]
BARIUM CARBONATE BARIUM CATION 28 [hp_X]
SUS SCROFA TONSIL Sus Scrofa Tonsil 28 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2.2 in 1 AMPULE
2 NDC:50114-0104-6 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1993-01-31


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