Label: THYREOIDEA COMPOSITUM- lactic acid, l- and viscum album and colchicum autumnale bulb and conium maculatum flowering top and galium aparine and fucus vesiculosus and sedum acre and sempervivum tectorum leaf and adenosine triphosphate and fumaric acid and alpha-ketoglutaric acid and malic acid and sodium diethyloxalacetate and pulsatilla vulgaris and spongia officinalis skeleton, roasted and sus scrofa thyroid and calcium fluoride and sus scrofa umbilical cord and pork liver and sus scrofa bone marrow and sus scrofa spleen injection
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Contains inactivated NDC Code(s)
NDC Code(s): 50114-7041-1 - Packager: Heel Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated July 8, 2011
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DESCRIPTION
Injection Solution Ingredient Information: Each 2.2ml ampule contains: Sarcolacticum acidum 3X, Viscum album 3X, Colchicum autumnale 4X, Conium maculatum 4X, Galium aparine 4X, Fucus vesiculosus 6X, Sedum acre 6X, Sempervivum tectorum 6X, ATP Adenosine triphosphate 8X, Fumaricum acidum 8X, α-Ketoglutaricum acidum 8X, Malicum acidum 8X, Natrum oxalaceticum 8X, Pulsatilla 8X, Spongia tosta 8X, Thyreoidea suis 8X, Calcarea fuorica 10X, Funiculus umbilicalis suis 10X, Hepar suis 10X, Medulla ossis suis 10X, Splen suis 10X, Sulphur 10X, Thymus suis 10X, Cortisone aceticum 28X 22mcl each. Inactive ingredient: Sterile isotonic sodium chloride solution. - INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
The dosage schedules listed below can be used as a general guide for the administration of Thyreoidea compositum® Injection Solution. Thyreoidea compositum® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient’s response to therapy. Adults and children 7 years and older: in acute disorders, 1 ampule per day, otherwise 1 ampule, 1 to 3 times per week IM/SC/IV/ID.Children ages 2 to 6 receive ½ the adult dosage.
Discard unused solution.
Thyreoidea compositum® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Thyreoidea compositum® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefy. Thyreoidea compositum® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Thyreoidea compositum® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Thyreoidea compositum® Injection Solution is a clear, colorless solution. Discolored solutions should be discarded.
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WARNINGS AND PRECAUTIONS
If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should be carefully re-evaluated because these could be signs of a serious condition.
Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.
To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch - OVERDOASGE
- CLINICAL PHARMACOLOGY
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THYREOIDEA COMPOSITUM
lactic acid, l- and viscum album and colchicum autumnale bulb and conium maculatum flowering top and galium aparine and fucus vesiculosus and sedum acre and sempervivum tectorum leaf and adenosine triphosphate and fumaric acid and alpha-ketoglutaric acid and malic acid and sodium diethyloxalacetate and pulsatilla vulgaris and spongia officinalis skeleton, roasted and sus scrofa thyroid and calcium fluoride and sus scrofa umbilical cord and pork liver and sus scrofa bone marrow and sus scrofa spleen injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50114-7041 Route of Administration INTRAMUSCULAR, SUBCUTANEOUS, INTRAVENOUS, INTRADERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L- 3 [hp_X] in 2.2 mL COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 4 [hp_X] in 2.2 mL CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP 4 [hp_X] in 2.2 mL GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE 4 [hp_X] in 2.2 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 6 [hp_X] in 2.2 mL SEDUM ACRE (UNII: 2496VW6S9J) (SEDUM ACRE - UNII:2496VW6S9J) SEDUM ACRE 6 [hp_X] in 2.2 mL SEMPERVIVUM TECTORUM LEAF (UNII: 3DGJ7BUA01) (SEMPERVIVUM TECTORUM LEAF - UNII:3DGJ7BUA01) SEMPERVIVUM TECTORUM LEAF 6 [hp_X] in 2.2 mL ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE 8 [hp_X] in 2.2 mL FUMARIC ACID (UNII: 88XHZ13131) (FUMARIC ACID - UNII:88XHZ13131) FUMARIC ACID 8 [hp_X] in 2.2 mL .ALPHA.-KETOGLUTARIC ACID (UNII: 8ID597Z82X) (.ALPHA.-KETOGLUTARIC ACID - UNII:8ID597Z82X) .ALPHA.-KETOGLUTARIC ACID 8 [hp_X] in 2.2 mL MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP) MALIC ACID 8 [hp_X] in 2.2 mL SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7) DIETHYL OXALACETATE 8 [hp_X] in 2.2 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 8 [hp_X] in 2.2 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 8 [hp_X] in 2.2 mL SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) SUS SCROFA THYROID 8 [hp_X] in 2.2 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (CALCIUM FLUORIDE - UNII:O3B55K4YKI) CALCIUM FLUORIDE 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 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 2.2 mL SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS 10 [hp_X] in 2.2 mL VISCUM ALBUM FRUIT (UNII: P83EQ521R3) (VISCUM ALBUM FRUIT - UNII:P83EQ521R3) VISCUM ALBUM FRUIT 3 [hp_X] in 2.2 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE 28 [hp_X] in 2.2 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50114-7041-1 10 in 1 CARTON 1 2.2 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/08/2011 Labeler - Heel Inc (102783016)