GALIUM-HEEL - betula pendula leaf, caltha palustris, sedum acre, thuja occidentalis leafy twig, clematis recta flowering top, hedera helix flowering twig, juniper berry, ononis spinosa whole, saponaria officinalis root, sempervivum tectorum leaf, echinacea, unspecified, nitric acid, rancid beef, silver, calcium fluoride, phosphorus, gold, apis mellifera, galium aparine, galium boreale leaf and urtica urens solution 
Heel 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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Galium_Heel Oral

DESCRIPTION

Ingredients Each 1.1 ml ampule contains:

Apis mellifica 

12X

0.55µ

Argentum metallicum 

X

0.55µ

Aurum metallicum 

10 x

0.55µ

Betula alba 

2X

0.55µ

Calcarea fluorica

8X

0.55µ

Caltha palustris 

3X

0.55µ

Clematis erecta 

4X

0.55µ

Echinacea

5X

0.55µ

Galium album 

3X

0.55µ

Galium aparine

3 X

0.55µ

Hedera helix

4X

0.55µ

Juniperus communis 

4X

0.55µ

Nitricum acidum 

6x

0.55µ

Ononis spinosa

4X

0.55µ

Phosphorus 

8X

0.55µ

Sedum acre 

3x

0.55µ

Sempervivum tectorum 

4X

0.55µ

Thuja occidentalis 

3X

0.55µ

Urtica urens

3X

0.55µ

INDICATION AND USAGE

 Galium-Heel® Oral Vial is a homeopathic drug indicated for stimulation for the defense mechanism in chronic illness and viral infections such as colds and flu.

DOSAGE AND ADMINISTRATION

General Considerations

  • The dosage schedules listed below can be used as a general guide for the administration of Galium-Heel® Oral Vials
  • Discard any unused oral vial content.

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

Galium-Heel® Oral Vials are contraindicated in patients with known hypersensitivity to Galium-Heel® or any of its ingredients

WARNINGS AND PRECAUTIONS

Warnings and Precautions

None

ADVERSE REACTIONS

No adverse events have been reported with a causal relationship to Galium-Heel® ® 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 Galium-Heel® Oral Vials is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 oral vial containing 1.1 ml solution for oral administration




Galium-Heel Oral Vial.jpg

GALIUM-HEEL 
betula pendula leaf,caltha palustris,sedum acre,thuja occidentalis leafy twig,clematis recta flowering top,hedera helix flowering twig, juniper berry, ononis spinosa whole,saponaria officinalis root, sempervivum tectorum leaf, echinacea, unspecified, nitric acid, rancid beef, silver, calcium fluoride, phosphorus,gold, apis mellifera, galium aparine, galium boreale leaf and urtica urens solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-5206
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETULA PENDULA LEAF (BETULA PENDULA LEAF) BETULA PENDULA LEAF2 [hp_X]  in 1.1 mL
CALTHA PALUSTRIS (CALTHA PALUSTRIS) CALTHA PALUSTRIS3 [hp_X]  in 1.1 mL
SEDUM ACRE (SEDUM ACRE) SEDUM ACRE3 [hp_X]  in 1.1 mL
THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 1.1 mL
CLEMATIS RECTA FLOWERING TOP (CLEMATIS RECTA FLOWERING TOP) CLEMATIS RECTA FLOWERING TOP4 [hp_X]  in 1.1 mL
HEDERA HELIX FLOWERING TWIG (HEDERA HELIX FLOWERING TWIG) HEDERA HELIX FLOWERING TWIG4 [hp_X]  in 1.1 mL
JUNIPER BERRY (JUNIPER BERRY) JUNIPER BERRY4 [hp_X]  in 1.1 mL
ONONIS SPINOSA WHOLE (ONONIS CAMPESTRIS) ONONIS SPINOSA WHOLE4 [hp_X]  in 1.1 mL
SAPONARIA OFFICINALIS ROOT (SAPONARIA OFFICINALIS ROOT) SAPONARIA OFFICINALIS ROOT4 [hp_X]  in 1.1 mL
SEMPERVIVUM TECTORUM LEAF (SEMPERVIVUM TECTORUM LEAF) SEMPERVIVUM TECTORUM LEAF4 [hp_X]  in 1.1 mL
ECHINACEA, UNSPECIFIED (ECHINACEA, UNSPECIFIED) ECHINACEA, UNSPECIFIED5 [hp_X]  in 1.1 mL
NITRIC ACID (NITRIC ACID) NITRIC ACID6 [hp_X]  in 1.1 mL
RANCID BEEF (RANCID BEEF) RANCID BEEF6 [hp_X]  in 1.1 mL
SILVER (SILVER) SILVER8 [hp_X]  in 1.1 mL
CALCIUM FLUORIDE (FLUORIDE ION) CALCIUM FLUORIDE8 [hp_X]  in 1.1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS8 [hp_X]  in 1.1 mL
GOLD (GOLD) GOLD10 [hp_X]  in 1.1 mL
APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA12 [hp_X]  in 1.1 mL
GALIUM APARINE (GALIUM APARINE) GALIUM APARINE3 [hp_X]  in 1.1 mL
GALIUM BOREALE LEAF (GALIUM BOREALE LEAF) GALIUM BOREALE LEAF3 [hp_X]  in 1.1 mL
URTICA URENS (URTICA URENS) URTICA URENS3 [hp_X]  in 1.1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-5206-610 in 1 CARTON
11.1 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/199308/18/2014
Labeler - Heel Inc (102783016)

Revised: 8/2014
 
Heel Inc