ENGYSTOL - cynanchum vincetoxicum root and sulfur injection 
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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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DESCRIPTION

 Each 1.1 ml solution for injection ampule contains:
 Active Ingredients:
 Ingredient name Potency Quantity Final dilution
 Asclepias vincetoxicum 6X 6.6 µl 8.22X
 Asclepias vincetoxicum 10X 6.6 µl 12.22X
 Asclepias vincetoxicum 30X 6.6 µl 32.22X
 Sulphur 4X 3.3 µl 6.52X
 Sulphur 10X 3.3 µl 12.52X

Inactive Ingredients:

Water for injection 1,073.6 μl

Sodium Chloride 8.78 μl

INDICATIONS AND USAGE

Engystol® Injection Solution is a homeopathic drug product indicated for the support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.

DOSAGE AND ADMINISTRATION

General Considerations

• The dosage schedules listed below can be used as a general guide for the administration of Engystol® Injection Solution.

• Engystol® Injection Solution may be administered s.c., i.d., i.m., or i.v.

• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents.

• Draw up required dose into syringe.

• Discard any unused ampule contents. Do not reuse ampule.

Standard Dosage:

Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.

Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.

Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.

Acute Dosage:

Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.

Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.

Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.

CONTRAINDICATIONS

Engystol® Injection Solution is contraindicated in patients with known hypersensitivity to Engystol® or any of its ingredients.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

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 Engystol® Injection Solution is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under Description.

Engystol Inj. Carton v.2.jpg

ENGYSTOL 
cynanchum vincetoxicum root and sulfur injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-7015
Route of AdministrationINTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CYNANCHUM VINCETOXICUM ROOT (CYNANCHUM VINCETOXICUM ROOT) CYNANCHUM VINCETOXICUM ROOT6 [hp_X]  in 1.1 mL
SULFUR (SULFUR) SULFUR4 [hp_X]  in 1.1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:50114-7015-110 in 1 CARTON
11.1 mL in 1 AMPULE
2NDC:50114-7015-21 in 1 CARTON
21.1 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/06/2011
Labeler - Heel Inc (102783016)

Revised: 07/2013
 
Heel Inc