Vitafol Gummies

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.