Vitafol Gummies

Basic Information

Product Label

Product label for Vitafol Gummies
Full Name: Vitafol Gummies
Brand: Exeltis USA none
Product Type: Other Combinations
Physical State: Gummy or Jelly
UPC/SKU: 3 06420 12590 4
Product Version Code: 1259002-04

Contact Information

Distributed by

Name: Exeltis USA, Inc.
Address:Florham Park, NJ, 07932
Phone: 1-877-324-9349
Website: www.exeltisUSA.com
Types: Distributor

Product Details

Net Contents

90 Gummy(ies)(90 Gummy(ies))

Serving Sizes

Unit:Gummy(ies)
Quantity:3 - 3
Daily Servings:1 - 1

Target Groups

Pregnant Women

Servings Per Container

30

Ingredients & Nutrition

Amount: 24 Calorie(s)
Serving Size: 3 Gummy(ies)

Group: Calories

UNII Code: 1

Choline

vitamin
Forms:
  • Choline Bitartrate
Amount: 10 mg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: % (Daily Value not established)

Group: Choline

Also known as: ch-OSA, VitaCholine, CDP-Choline

UNII Code: N91BDP6H0X

Folate

vitamin
Forms:
  • Folic Acid
Amount: 1700 mcg DFE
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 125%

Group: Vitamin B9 (Folate)

Iodine

mineral
Forms:
  • Potassium Iodide
Amount: 150 mcg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 100%

Group: Iodine

Iron

mineral
Forms:
  • Ferric Orthophosphate
Amount: 10 mg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 56%

Group: Iron

Niacin

vitamin
Forms:
  • Niacinamide
Amount: 15 mg NE
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 75%

Group: Niacin

Also known as: Vitamin B3, Vit. B-3, B3, Niacinol, Nicotinic Acid, B-3, Vitamin B-3

UNII Code: 2679MF687A

Amount: 104.5 mg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: % (Daily Value not established)

Group: Omega-3

UNII Code: 71M78END5S

Amount: 5 Gram(s)
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: % (Daily Value not established)

Group: Carbohydrate

UNII Code: 0

Vitamin A

vitamin
Forms:
  • Vitamin A Palmitate
Amount: 330 mcg RAE
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 14%

Group: Vitamin A (unspecified)

Forms:
  • Cyanocobalamin
Amount: 8 mcg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 100%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin
Forms:
  • Pyridoxine Hydrochloride
Amount: 2.5 mg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 100%

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 30 mg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 50%

Group: Vitamin C (unspecified)

Vitamin D

vitamin
Forms:
  • Cholecalciferol
Amount: 25 mcg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 250%

Group: Vitamin D

Vitamin E

vitamin
Forms:
  • D-Alpha-Tocopheryl Acetate
Amount: 6.75 mg
Serving Size: 3 Gummy(ies)
Pregnant and Lactating: 50%

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Group: Vitamin A

Also known as: Betatene, Vitamin A

UNII Code: 01YAE03M7J

Carnauba Wax

non-nutrient/non-botanical

Group: Carnauba wax

Group: Sugar cane

Also known as: Sugar

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Group: EPA (Eicosapentaenoic Acid)

Also known as: C20:5n-3, EPA

UNII Code: AAN7QOV9EA

EPA

fatty acid

Group: EPA (Eicosapentaenoic Acid)

Also known as: Eicosapentanoic Acid, Eicosapentaenoic Acid

Gelatin

protein

Group: Gelatin

Group: Glucose

Group: Collagen

Also known as: Gelatin

Lactic Acid

non-nutrient/non-botanical

Group: Lactic Acid

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

Group: Flavor

Group: Flavor

Group: Color

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Group: Omega-3

UNII Code: 71M78END5S

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Sugar

sugar

Group: Sugar

UNII Code: C151H8M554

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Water

other

Group: Water

Product Statements

Precautions re: All Other

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).

Precautions re: Children

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 Poison Control Center immediately.

Precautions re: All Other

Warnings/precautions: This product is intended for use as directed by your healthcare provider. Please do not share with others.

Precautions re: Allergies

Contains soybean and fish oil (cod).

Precautions re: All Other

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 form 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.

Precautions re: Children

Keep out of the reach of children.

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: Pregnant or Nursing or Prescription Medications

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

Precautions re: Children

Pediatric use: Not for pediatric use.

Precautions re: All Other

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.

Suggested/Recommended/Usage/Directions

Directions for use: During pregnancy, take 3 gummies once daily, or as directed by a physician.

General Statements: All Other Content

How supplied: Vitafol Gummies is available as a coated berry shaped gummy. Available in bottle of 90, 0642-0125-90 and as professional samples in bottle, 0642-0125-04. Rx

Storage

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

Formulation re: Other

Made in Colombia.

Brand IP Statement(s) re: (c), (TM), (SM)

Copyright 2021 Exeltis USA, Inc. Vitafol is a trademark of Exeltis USA, Inc. U.S. patent pending

Formula re: Contains

Prenatal vital nutrition with iron

General Statements: All Other Content

(30 days supply)

FDA Statement of Identity

Dietary Supplement

Formula re: Type

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

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