VITAFOL FE PLUS- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iodine, iron, magnesium, zinc, copper, doconexent, and docusate sodium 
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.

----------

Vitafol® Fe+ Supplement
Prenatal Supplement with 90 mg Iron, and Optional Stool
Softener

Rx

Prenatal Supplement

COMPOSITION

Each PURPLE softgel capsule contains:

Vitamin A (as beta carotene) 1100 IU
Vitamin C (as ascorbic acid) 60 mg
Vitamin D (as cholecalciferol) 1000 IU
Vitamin E (as dl-alpha tocopheryl acetate) 20 IU
Thiamin (Vitamin B1) 1.6 mg
Riboflavin (Vitamin B2) 1.8 mg
Niacin (as niacinamide) 15 mg
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg
Folate1 mg
  (as Folic acid USP 0.4 mg; as L-methylfolate calcium 0.6 mg)
Vitamin B12 (as cyanocobalamin) 25 mcg
Iron (as polysaccharide iron complex) 90 mg
Iodine (as potassium iodide) 150 mcg
Magnesium (as magnesium oxide) 20 mg
Zinc (as zinc oxide) 25 mg
Copper (as copper oxide) 2 mg
Algal oil (from crypthecodinium cohnii)
  providing 200 mg DHA (docosahexaenoic acid)
415mg

Other Ingredients: Gelatin, Soybean Oil, Sorbitol, Glycerin, Yellow Beeswax, USP Purified Water, Lecithin, Titanium Dioxide (as colorant), FD&C Red #40, FD&C Blue #1, White Edible Ink.

Contains: Soy. May also contain: Corn Oil, DL alpha-tocopherol, Medium Chain Triglycerides.

USAGE

Vitafol® Fe+ prenatal supplement provides vitamin, mineral and omega-3 fatty acid supplementation throughout pregnancy, including individuals with known allergies to fish. Vitafol® Fe+ does not contain fish, fish oils, fish proteins, or fish by-products.

CONTRAINDICATIONS

Vitafol® Fe+ prenatal supplement 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 supplementation 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. Do not share with others. Vitafol® Fe+ must 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 levels in blood.

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, 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.

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 substantially higher than those in Vitafol® Fe+. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Stool Softener Supplement

COMPOSITION

Each WHITE softgel capsule contains: Docusate sodium, 50 mg

Other Ingredients: Gelatin, Sorbitol, Polyethylene Glycol, Glycerin, Purified Water, Propylene Glycol, Titanium Dioxide, Citric Acid, Black Edible Ink.

USAGE

Helps maintain bowel regularity and to provide relief from occasional constipation which may occur during pregnancy or associated with use of supplements containing iron.

WARNINGS/PRECAUTIONS

Ask a doctor before use if you have stomach pain, nausea, or vomiting; or a sudden change in bowel habits that lasts over 14 days.

Ask your doctor before use if you are breastfeeding.

Ask a doctor or pharmacist before use if you are presently taking mineral oil, or other laxative products.

Stop use and ask a doctor if you have rectal bleeding or no bowel movement after using this product, as these could be signs of a serious condition.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS FOR USE

Take one purple softgel capsule daily during pregnancy, or as directed by a physician.

Take one white softgel capsule daily, or as needed to help relieve occasional constipation. Take with water. May be taken at the same time as the prenatal supplement or separately.

HOW SUPPLIED

Vitafol® Fe+ is available as a purple, oval shaped softgel capsule imprinted "EX0096" and one white, oval shaped softgel capsule imprinted "50". Available in box of Unit-Dose pack of 30 (6 child resistant blister cards of 5+5 softgel capsules), Item No. 0642-0096-30 and as professional samples Item No. 0642-0096-01.

Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat 40°C (104°F), light and moisture.

Please dispose of any unused capsules promptly, and properly.

You should call your doctor for medical advice about adverse or unexpected reactions. To report to the company an adverse event or obtain product information, call 1-877-324-9349.

Manufactured in the USA.

Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932

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
Life's DHA™ is a trademark of DSM. U.S.A.
Patent No. 7,163,811 and 7,824,892
Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany.
U.S. Patent No. 6,441,168; 5,997,915; 6,254,904; 6,808,725,
7,172,778 and 7,674,490

(Rev.08/15)

PRINCIPAL DISPLAY PANEL - Kit Carton

SAMPLE NOT FOR SALE
0642-0096-01

Vitafol® Fe+
COMPLETE PRENATAL SUPPLEMENT WITH 90 mg IRON

Small, Once Daily Softgel
with 16 Key Nutrients

+ Optional stool softener softgel

3-Day
Starter Pack

Rx
U.S. Patent Pending

Principal Display Panel - Kit Carton
VITAFOL FE PLUS 
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iodine, iron, magnesium, zinc, copper, doconexent, and docusate sodium kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0096
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0642-0096-011 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK
Part 21 BLISTER PACK
Part 1 of 2
VITAFOL FE PLUS   PRENATAL SUPPLEMENT
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iodine, iron, magnesium, zinc, copper, and doconexent capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A1100 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D1000 [iU]
.Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol20 [iU]
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin15 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin25 ug
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine150 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron90 mg
Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium20 mg
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc25 mg
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper2 mg
Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent200 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin (UNII: 2G86QN327L)  
Soybean Oil (UNII: 241ATL177A)  
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Water (UNII: 059QF0KO0R)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Corn Oil (UNII: 8470G57WFM)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize17mm
FlavorImprint Code EX0096
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/01/2015
Part 2 of 2
VITAFOL FE PLUS   STOOL SOFTENER SUPPLEMENT
docusate sodium capsule, liquid filled
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium50 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin (UNII: 2G86QN327L)  
Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorImprint Code 50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
15 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT10/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/01/2015
Labeler - Exeltis USA, Inc. (071170534)

Revised: 9/2015
Document Id: 0b5e21c3-371b-409d-ba8a-0cf85f69d242
Set id: f02b9e2f-426a-45e8-b98f-a6f382f9a28e
Version: 1
Effective Time: 20150922
 
Exeltis USA, Inc.