CARDIOTEK-RX- bioperine, folic acid, l-arginine hcl, vitamin b-12, vitamin b6 tablet, coated

CARDIOTEK-RX by

Drug Labeling and Warnings

CARDIOTEK-RX by is a Other medication manufactured, distributed, or labeled by SJ PHARMACEUTICALS, LLC, NEXGEN PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

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:

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.

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-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:

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.

PRECAUTIONS:

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:

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

WARNING:

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

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

INGREDIENTS AND APPEARANCE

CARDIOTEK-RX 
bioperine, folic acid, l-arginine hcl, vitamin b-12, vitamin b6 tablet, coated

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:24839-333
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF)	BLACK PEPPER	5 mg  in 58 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	2 mg  in 58 mg
ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F)	ARGININE	.5 mg  in 58 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	.5 mg  in 58 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	50 mg  in 58 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24839-333-30	1740 mg in 1 BOTTLE
2	NHRIC:24839-333-99	58 mg in 1 DOSE PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		05/01/2008

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
imprint
scoring	1
size (solid drugs)	8 mm

Labeler - SJ PHARMACEUTICALS, LLC (845662720)

Registrant - NEXGEN PHARMA (040488621)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA		040488621	manufacture(24839-333)