NDC 0642-0092 Vitafol Plus

NDC Product Code 0642-0092

NDC 0642-0092-01

Package Description: 1 BLISTER PACK in 1 BOX > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC 0642-0092-30

Package Description: 5 BLISTER PACK in 1 BOX > 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Vitafol Plus with NDC 0642-0092 is a product labeled by Everett Laboratories, Inc.. The generic name of Vitafol Plus is . The product's dosage form is and is administered via form.

Labeler Name: Everett Laboratories, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GELATIN (UNII: 2G86QN327L)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Everett Laboratories, Inc.
Labeler Code: 0642
Start Marketing Date: 04-23-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Vitafol Plus Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx only

Rx onlyManufactured forEVERETT LABORATORIES, INC.West Orange, NJ 070521-877-324-9349Patent PendingVitafol® is a trademark of Everett Laboratories, Inc.life's DHA is a trademark of DSM.U.S. Patent No. 5,492,938; 7,163,811(Rev. 03/12)

Composition

Each Softgel Capsule Contains:Vitamins and Minerals:Vitamin A (as beta carotene)1100 IUVitamin C (as ascorbic acid)12 mgVitamin D3 (as cholecalciferol)1000 IUVitamin E (as dl-alpha tocopheryl acetate)10 IUThiamin (Vitamin B1) (as thiamine mononitrate)1.6 mgRiboflavin (Vitamin B2)1.8 mgNiacin (as nicotinamide)15 mgVitamin B6 (as pyridoxine hydrochloride)2.5 mgFolic Acid1 mgVitamin B12 (as cyanocobalamin)12 mcg Elemental Iron (as polysaccharide iron complex)27mgIodine (as potassium iodide)200 mcgMagnesium (as magnesium oxide)5 mgZinc (as zinc oxide)15 mgCopper (as copper oxide)2 mgLauric Acid60 mgOmega-3 FATTY ACIDDHA from Algal (crypthecodinium) Oil200 mg

Other Ingredients

Gelatin, Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Soy Lecithin, FD&C Blue #1, Titanium Dioxide (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate, FD&C Yellow #5, FD&C Red #40.

Indications And Usage

Vitafol®-Plus is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.

Contraindications

Vitafol®-Plus 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 B-12)

Warning

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

Warning/Precautions

Vitafol-Plus should be used with caution in patients with known sensitivity or allergy to soy.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.Avoid Overdosage. 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, and 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 pregnancy and breast-feeding, and the use of all medications and dietary supplements.

Pediatric Use

Not for Pediatric Use.

Adverse Reactions

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

Dosage And Administration

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

Storage And Handling

Vitafol®-Plus is available as a purple, oval shaped softgel capsule imprinted EV0092. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules) (NDC0642-0092-30), and as professional samples (NDC0642-0092-01). Store at room temperature, approximately 15°-30°C (59°-86°F). Avoid excessive heat, moisture and protect from light.

* Please review the disclaimer below.