CRALONIN - crataegus laevigata flower, spigelia anthelmia and potassium bromide 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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Cralonin oral vial

DESCRIPTION

Each 1.1 ml ampule contains:

Ingedient

Potency

Quantity

Crataegus oxyacantha

2X

11µ

Spigelia anthelmia

1X

11µ

Kali carbonicum

2X

11µ

Inactive Ingedient: Isotonic Sodium chloride solution

INDICTION AND USAGE

Cralonin indicated for the ancillary treatment of myocardial weakness

DOSAGE AND ADMINISTRATION

Adults: In general, 1 vial 1-3 times daily orally by mouth. 

CONTRAINDICATIONS

Cralonin oral vials are contraindicated in patients with known sensitivity to Cralonin or any of its ingerdients.

WARNINGS AND PRECAUTIONS

Warnings and Precautions

None

ADVERSE REACTIONS

No adverse events have been reported with a casual relationship to Cralonin oral vials

OVERDOSAGE

Overdosage: No negative effects of an overdose have been reported

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Cralonin oral vial is not fully understood

Dosage

1 oral vial containing 1.1 ml solution for oral administration

Cralonin oral vial.jpg

CRALONIN 
crataegus laevigata flower, spigelia anthelmia and potassium bromide solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-5165
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CRATAEGUS LAEVIGATA FLOWER (CRATAEGUS LAEVIGATA FLOWER) CRATAEGUS LAEVIGATA FLOWER6 [hp_X]  in 1.1 mL
SPIGELIA ANTHELMIA (SPIGELIA ANTHELMIA) SPIGELIA ANTHELMIA1 [hp_X]  in 1.1 mL
POTASSIUM BROMIDE (BROMIDE ION) POTASSIUM BROMIDE2 [hp_X]  in 1.1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-5165-610 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