VITAFOL- cholecalciferol, pyridoxine hydrochloride, cyanocobalamin, and folic acid strip

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41), Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z), Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204), Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)

זמין מ:

Exeltis USA, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Vitafol® Strips is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

leaflet_short:

Vitafol® Strips is available as an orange rectangular film with "V" logo printed on one side. Available in Box of Unit-Dose pack in pouch of 30 counts, Item No. 0642-7468-30 and as physician sample in pouch of 3 counts, Item No. 0642-7468-01. Store at room temperature, approximately 20°-25°C (68°-77°F), avoid excessive heat, moisture and protect from light. To report suspected adverse event contact Exeltis USA, Inc., at 1-877-324-9349 or at FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

מצב אישור:

unapproved drug other

מאפייני מוצר

VITAFOL- CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN,
AND FOLIC ACID STRIP
EXELTIS USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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VITAFOL STRIPS
PRENATAL SUPPLEMENT
0642-7468-30
RX ONLY
These statements have not been evaluated by the Food and Drug
Administration. This product is not
intended to diagnose, treat, cure, or prevent any disease.
COMPOSITION
Amount per daily dose (1 strip)
VITAMINS AND MINERALS:
Calories
1
Total Carbohydrates
0 g
Sugars
0 g
Vitamin B6 (as pyridoxine hydrochloride)
2.5 mg
Folic Acid
1 mg
Vitamin B12 (as cyanocobalamin)
12 mcg
Vitamin D (as cholecalciferol)
1000 IU
OTHER INGREDIENTS:
Sentry Polyox WSR N80 LEO, maltitol syrup, methocel (hydroxypropyl
methylcellulose), sodium
citrate anhydrous, lemon flavor, sucralose, butylated hydroxytoluene,
peceol, water.
USAGE
Vitafol
Strips provides vitamin and mineral supplementation prior to
conception, throughout
pregnancy, and postnatal period for the lactating and non-lactating
women.
CONTRAINDICATIONS
Vitafol
Strips is contraindicated in patients with hypersensitivity to any of
its components or color
additives.
Folic acid is contraindicated in patients with untreated and
uncomplicated pernicious anemia, and in
those with anaphylactic sensitivity to folic acid.
Cyanocobalamin is contraindicated in patients with sensitivity to
cobalt or to cyanocobalamin (vitamin
B12).
WARNINGS/PRECAUTIONS
®
®
®
This product is intended for use as directed by your healthcare
provider. Please do not share with
others.
Vitamin D supplementation should be used with caution in those with
hypercalcemia or conditions that
may lead to hypercalcemia such as hyperparathyroidism and those who
form calcium-containing kidney
stones. High doses of vitamin D can lead to elevated levels of calcium
that reside in the blood and soft
tissues. Bone pain, high blood pressure, formation of kidney stones,
rena