VITAFOL Gummies: Package Insert and Label Information

VITAFOL GUMMIES- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, iodine, choline, doconexent, icosapent and omega-3 fatty acids tablet, chewable
Exeltis USA, Inc.

Prenatal Supplement with Iron Rx

COMPOSITION

Amount per daily dose (3 gummies)

VITAMINS AND MINERALS:
Calories 24
Total Carbohydrates 5 g
Sugars 5 g
Vitamin A (as Vitamin A palmitate) 1100 IU
Vitamin C (as ascorbic acid) 30 mg
Vitamin D (as cholecalciferol) 1000 IU
Vitamin E (as d-alpha tocopheryl acetate) 15 IU
Niacin (as niacinamide) 15 mg
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg
Folic Acid 1 mg
Vitamin B12 (as cyanocobalamin) 8 mcg
Iron (as ferric orthophosphate) 10 mg
Iodine (as potassium iodide) 150 mcg
Choline (as choline bitartrate) 10 mg
Omega 3 fatty acid 104.5 mg
Docosahexaenoic acid (DHA) 75 mg
Eicosapentaenoic acid (EPA) 15.3 mg
Other Omega 3 fatty acid 14.2 mg

Other Ingredients: Sugar, glucose syrup, water, gelatin, lactic acid, citric acid, mixed berry flavor, Certicoat 580 (contains mineral oil and Carnauba wax), Natural Color and Masking flavor.

Contains soybean and fish oil (cod).

USAGE

Vitafol® Gummies is indicated to provide vitamin, mineral, and DHA supplementation throughout pregnancy.

CONTRAINDICATIONS

Vitafol® Gummies 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.

Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS

This product is intended for use as directed by your healthcare provider. Please do not share with others. Contains soybean and fish oil (cod).

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, renal failure, and increased risk of heart disease can occur.

Iodine should be used with caution in patients with an overactive thyroid.

Prolonged use of iron salts may produce iron storage disease.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.

Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.

Do not use if inner seal is broken or missing.
Do not exceed recommended dose.
Keep out of the reach of children.

Drug Interactions

Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.

Medications for hypertension used in conjunction with iodine supplementation may increase potassium.

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient’s response to methotrexate.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions.

Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients

Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.

Pediatric Use

Not for pediatric use.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses higher than those in Vitafol® Gummies. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

DIRECTIONS FOR USE

During pregnancy, take 3 gummies once daily, or as directed by a physician.

HOW SUPPLIED

Vitafol® Gummies is available as a coated berry shaped gummy. Available in bottle of 90, Item No. 0642-0125-90 and as professional samples, in bottle with 3 gummies, Item No. 0642-0125-04.

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.

You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349

Made in Colombia.
Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349

www.exeltisUSA.com
©2019 Exeltis USA, Inc.

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.

Vitafol® is a trademark of Exeltis USA, Inc.
U.S. Patent Pending

Rev. July-2019
1250301-02

PRINCIPAL DISPLAY PANEL — 90 gummies Bottle Label

0642-0125-90

VITAFOL
gummies

Prenatal Vital Nutrition with iron

90 gummies (30 Days Supply)

RX
DIETARY SUPPLEMENT

Principal Display Panel -- 90 gummies Bottle Label
(click image for full-size original)
VITAFOL GUMMIES
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, iodine, choline, doconexent, icosapent, and omega-3 fatty acids tablet, chewable
Product Information
Product Type Item Code (Source) NDC:0642-0125
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 1100 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 30 mg
Vitamin D (Cholecalciferol) Vitamin D 1000 [iU]
.Alpha.-Tocopherol (.Alpha.-Tocopherol) .Alpha.-Tocopherol 15 [iU]
Niacin (Niacin) Niacin 15 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 8 ug
Iron (Iron) Iron 10 mg
Iodine (Iodine) Iodine 150 ug
Choline (Choline) Choline 10 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 75 mg
Icosapent (Icosapent) Icosapent 15.3 mg
Omega-3 Fatty Acids (Omega-3 Fatty Acids) Omega-3 Fatty Acids 14.2 mg
Inactive Ingredients
Ingredient Name Strength
Sucrose
Corn Syrup
Water
GELATIN, UNSPECIFIED
Lactic Acid, Unspecified Form
Citric Acid Monohydrate
Keracyanin
Propylene Glycol
Product Characteristics
Color PURPLE Score no score
Shape FREEFORM (Berry design) Size 20mm
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0642-0125-90 90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC None
2 NDC:0642-0125-04 3 TABLET, CHEWABLE in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 05/01/2016
Labeler — Exeltis USA, Inc. (071170534)

Revised: 10/2019 Exeltis USA, Inc.

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