CARDIOTEK-RX

Manufacturer
SJ PHARMACEUTICALS, LLC | NEXGEN PHARMA
Effective date
2018-04-26
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:58

Label at a glance#

ProductCARDIOTEK-RX
Active ingredientBLACK PEPPER, FOLIC ACID, ARGININE, CYANOCOBALAMIN, PYRIDOXINE
Label structure5 sections

Dosage and administration

Adult dosage 1 to 2 tablets daily, or as prescribed by a physician or practitioner. Not recommended for use in pediatrics.

Label contents#

Full prescribing information#

DESCRIPTION:

STATEMENT OF IDENTITY SECTION

Cardiotek®-RX is a multi-B arginine supplement containing
essential cofactors in reducing elevated homocysteine levels.

DESCRIPTION:

Each orange, football-shaped coated tablet contains:
Bioperine® (Black Pepper Extract) ...................... 5 mg
Folic Acid ............................................................ 2 mg
L-Arginine HCl ................................................ 500 mg
Cyanocobalamin (Vitamin B12) ...................... 500 mcg
Pyridoxine (Vitamin B6) .................................... 50 mg
Also contains the following inactive ingredients:
croscarmellose sodium, dicalcium phosphate, FD&C yellow
no. 6 aluminum lake, hydroxypropyl cellulose, hypromellose,
magnesium stearate, microcrystalline cellulose, polydextrose,
polyethylene glycol, stearic acid, titanium dioxide, triacetin.
Cardiotek®-RX tablets are free of sugar, lactose and gluten.

Bioperine® increases bioavailability of folic acid, Vitamin B6,
and Vitamin B12, and has the following chemical structure:

BioperineBioperine

Folic Acid is yellowish-orange crystal. The chemical name is
N-[4[ [ (2-Amino-1, 4-dihydro-4-oxo-6-pteridinyl)methyl]
amino]benzoyl]-L-glutamic acid. Its empirical formula is
C19H19N7O6.
The use of supplemental folic acid
may be indicated in patients with
increased requirements for this
vitamin. Folic acid administration may
reduce the risk of neural tube defects
in the developing fetus. Folate as
5-methyltetrahydrofolate and Vitamin
B12 as methylcobalamin participate in
the remethylation reaction of
homocysteine to methionine.

Folic AcidFolic Acid


L-Arginine is a basic amino acid with
the molecular formula C6H14N4O2 and
with a molecular weight of 174.20. It
has 3 pKs: pK1=2.18, pK2=9.09 and
pK3=13.2. Therefore, it carries a
positive charge at physiological pH.
The stereoisomer of L-arginine,
D-arginine, does not have any
biological activity, as far as we know.
L-Arginine is also known as
2-amino-5- guanidinovaleric acid and
(S)-2-amino-5- [(aminoiminomethyl)
amino] pentanoic acid. Its one-letter
abbreviation is R. It is also
abbreviated as Arg. The terms
L-arginine and arginine are frequently
used interchangeably. The structural
formula of L-arginine is as follows:

L-ArginineL-Arginine
L-Arginine shows promise as a
nutritional adjunct in patients
undergoing treatment for
cardiovascular disease (including
atherosclerosis, hypertension,
hyperlipidemia and angina pectoris),
some forms of male infertility and
some kidney disorders and for wound
healing in some circumstances.
There is preliminary evidence that it
could be helpful as a nutritional
adjunct in some men undergoing
treatment for erectile dysfunction and
in some others being treated for
migraine, liver disease and primary
ciliary dyskinesia. There is conflicting
but mostly negative evidence related
to claims that it can improve exercise
performance and promote lean
muscle mass.
Cyanocobalamin (Vitamin B12)
appears as dark red crystals or
crystalline red powder. The chemical
name is 5,6-dimethylbenzimidazolyl
cyanocobamide. Its empirical
formula is C63H88CoN14O14P. The
structural formula of
Cyanocobalamin is as follows:

Vitamin B12Vitamin B12
Pyridoxine (Vitamin B6) is a
colorless or white crystal or a white
crystalline powder. It is stable in air
and is slowly affected by sunlight.
The chemical name is 2-methly-3
hydroxy-4, 5-bis (hydroxymethyl)
pyridine. Pyridoxine’s empirical
formula is C8H11NO3. A pyridine
derivative, C18H11NO3, occurring
especially in cereals, yeast, liver, and
fish and serving as a coenzyme in
amino acid synthesis.

Vitamin B6Vitamin B6

PRECAUTIONS:

PRECAUTIONS SECTION

Folic acid in doses above 1 mg daily
may obscure pernicious anemia in that hematologic
remission can occur while neurological manifestations
remain progressive. An oral dose of 100-250 mcg/day
will maintain adequate serum Vitamin B12 levels in
most patients with pernicious anemia, although some
patients may require as much as 1,000 mcg/day. Those
with renal or hepatic failure should exercise caution in
the use of supplemental L-arginine. Proteins of the
herpes simplex virus are rich in L-arginine, and there
are a few reports (mainly anecdotal) of those taking
supplemental L-arginine who ave had recurrences of oral
herpes lesions. Although it is unlikely that those with a
history of herpes simplex virus infection will have
recurrences if they use L-arginine supplements, they
should nevertheless be aware of this possibility.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Adult dosage 1 to 2
tablets daily, or as prescribed by a physician or
practitioner.
Not recommended for use in pediatrics.

WARNING:

WARNINGS SECTION

Keep this and all medicine out of the reach of
children.
is a registered trademark of
Sabinsa Corporation. Patent Numbers:
6,849,645/5,972,382/5,744,161/5,536,506/6,054,585
Rx only
Distributed by:
SJ Pharmaceuticals, LLC
1212 Collier Road NW
Atlanta, GA 30318
Rev. 10/17 7102

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 24839-333-30
CARDIOTEK®-RX TABLETS
Multi-B and Arginine Supplement

Each tablet contains:
Bioperine® (Black Pepper Extract) .. 5 mg
Folic Acid ...................................... 2 mg
L-Arginine HCl .......................... 500 mg
Vitamin B12 .............................. 500 mcg
Vitamin B6 .................................. 50 mg

SJ Pharmaceuticals, LLC

Rx only CONTENTS: 30 Tablets

DOSAGE AND ADMINISTRATION:
Adult dosage 1 to 2 tablets daily, or as
prescribed by a physician or practitioner.
Not recommended for use in pediatrics.


KEEP THIS AND ALL MEDICINE
OUT OF THE REACH OF CHILDREN.
Pharmacist: Dispense in a tight, lightresistant
container as defined in the
USP/NF with a child resistant closure.
Store at room temperature 15°C to 30°C
(59°F-86°F).
BIOPERINE®
is a registered trademark
of Sabinsa Corporation.

Patent Numbers: 6,849,645/5,972,382/
5,744,161/5,536,506/6,054,585
Distributed by:
SJ Pharmaceuticals, LLC
1212 Collier Road NW
Atlanta, GA 30318
Rev. 10/17

PACKAGE LABELPACKAGE LABEL

LABEL INSERTLABEL INSERT

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BLACK PEPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24839-333-30CARDIOTEK-RX1740 mg in 1 BOTTLETABLET, COATED17401
24839-333-99CARDIOTEK-RX58 mg in 1 DOSE PACKTABLET, COATED581

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24839-333CARDIOTEK-RX (BIOPERINE, FOLIC ACID, L-ARGININE HCL, VITAMIN B-12, VITAMIN B6) TABLET, COATED [SJ PHARMACEUTICALS, LLC]12 package rows20180507_19cdb5f7-8dd6-4d06-901c-ed0f4689a2e6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24839-333-30EA - Each24839-333a04211c9-00f7-41fd-a302-9393c08b12f412018-05-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24839-33324839-333-30, 24839-333-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.