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Cralonin

Heel Inc

Cralonin oral vial


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CRALONIN 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

CRALONIN DOSAGE AND ADMINISTRATION

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

CRALONIN 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

CRALONIN 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

Cralonin

CRATAEGUS LAEVIGATA FLOWER, SPIGELIA ANTHELMIA and POTASSIUM BROMIDE SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:50114-5165
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CRATAEGUS LAEVIGATA FLOWER CRATAEGUS LAEVIGATA FLOWER 6 [hp_X]
SPIGELIA ANTHELMIA SPIGELIA ANTHELMIA 1 [hp_X]
POTASSIUM BROMIDE POTASSIUM CATION 2 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1.1 in 1 AMPULE
2 NDC:50114-5165-6 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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