VP-ZEL- niacinamide, pyridoxine, folic acid, zinc oxide, cupric oxide, and azelaic acid tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L), AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT)

Available from:

Virtus Pharmaceuticals

INN (International Name):

NIACINAMIDE

Composition:

NIACINAMIDE 600 mg

Administration route:

ORAL

Therapeutic indications:

This product is contraindicated in patients with a known hypersensitivity to any of its ingredients.

Product summary:

VP-ZEL Tabs are supplied as coated, purple colored, oval-shaped tablets debossed on one side with "V221", and are supplied in bottles of 60 tablets. Store at Room Temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

Authorization status:

Dietary Supplement

Summary of Product characteristics

VP-ZEL- NIACINAMIDE, PYRIDOXINE, FOLIC ACID, ZINC OXIDE, CUPRIC OXIDE,
AND AZELAIC ACID TABLET
VIRTUS PHARMACEUTICALS
----------
VP-ZEL TABS
Prescription Dietary Supplement
69543-221-60
R
DESCRIPTION
VP-ZEL Tabs is an orally administered prescription dietary supplement
specifically formulated for the
dietary management of patients requiring increased folate levels and
nutritional supplementation in
addition to their dietary intake.
VP-ZEL Tabs should be administered under the supervision of a licensed
medical practitioner.
DIRECTIONS FOR USE
Usual adult serving is one tablet taken once or twice a day, with or
without food, or as directed by a
licensed medical practitioner.
Folate therapy alone is inadequate for treatment of a vitamin B
deficiency.
Not for use by pregnant or nursing women. Not for use by children.
SUPPLEMENT FACTS
SERVING SIZE: 1
TABLET
AMOUNT
PER SERVING
% DAILY VALUE
*
†
NICOTINAMIDE
(Vitamin B )
600 mg
3000%
PYRIDOXINE (Vitamin
B )
5 mg
250%
FOLIC ACID
500 mcg
125%
ZINC (Zinc Oxide)
10 mg
67%
COPPER (Cupric
Oxide)
1.5 mg
75%
AZELAIC ACID
5 mg
OTHER INGREDIENTS: Microcrystalline Cellulose, Pregelatinized Starch,
Purple Color Coating
(Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polyvinyl Alcohol,
Hydroxypropyl Cellulose,
Polyethylene Glycol, Talc, FD&C Red #40 Lake, FD&C Blue #1 Lake),
Silicon Dioxide, Stearic Acid,
TriPotassium Citrate, Citric Acid, Magnesium Stearate, and Fumed
Silica.
CONTAINS FD&C RED # 40 LAKE AND FD&C BLUE # 1 LAKE.
X
12
Azelaic acid is an organic compound with the formula
(CH )7(CO H)
[or also as C H
O ], and has CAS
number 123-99-9. It is in the dicarboxylic acid
(saturated) group, and occurs naturally in wheat, rye,
and barley.
2
2
2
9
16
4
Daily Value not established
3
6
*
†
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.
CONTRAINDICATIONS
This product is contraindicated in patients with a known
hypersensitivity to any of its ingredients.
CAUTION
High levels of folic acid may, especially in older adults, hide signs
of vitamin B-12 deficiency (such as
pernicious