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Vitafol-OB+DHA

Generic Name: prenatal supplement with DHA
Dosage Form: caplets, capsules

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®-OB+DHA
Prenatal Supplement with DHA

Rx

COMPOSITION

*
(providing 250 mg DHA (docosahexaenoic acid))
Each Vitafol®-OB caplet contains:
Vitamin A (as beta carotene) 2700 IU
Vitamin C (as ascorbic acid) 70 mg
Vitamin D3 (as cholecalciferol) 400 IU
Vitamin E (as dl-alpha tocopheryl acetate) 30 IU
Thiamine mononitrate (Vitamin B1) 1.6 mg
Riboflavin (Vitamin B2) 1.8 mg
Niacin (as niacinamide) 18 mg
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg
Folic acid 1.0 mg
Vitamin B12 (as cyanocobalamin) 12 mcg
Calcium (as calcium carbonate) 100 mg
Iron (as ferrous fumarate) 65 mg
Magnesium (as magnesium oxide) 25 mg
Zinc (as zinc oxide) 25 mg
Copper (as copper oxide) 2 mg
   
Each DHA softgel capsule contains:
Algal oil blend (derived from crypthecodinium cohnii, CAS #1258273-84-5) 486 mg*

Other Ingredients in Vitafol® -OB caplet: Microcrystalline Cellulose, hydrolyzed gelatin (pig skin), modified cellulose gum, stearic acid, hydroxypropylmethylcellulose, titanium dioxide (as color), polydextrose, silicon dioxide, gelatin, magnesium stearate, modified food starch, sucrose, maize starch, triacetin, dibasic calcium phosphate, hydroxypropylcellulose, FD&C Blue #1 Aluminum Lake,polyethylene glycol, sodium ascorbate, tocopherol concentrate, FD&C Blue #2 Aluminum Lake, medium chain trglycerides, sorbic acid, tribasic calcium phosphate, sodium benzoate, dl-alpha-tocopherol.Contains: Soy

Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.

Indications and Usage for Vitafol-OB+DHA

Vitafol®-OB+DHA 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®-OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts.

Contraindications

Vitafol®-OB +DHA 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 reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS

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.

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

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.

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 substantially higher than those in Vitafol®-OB+DHA. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.

Vitafol-OB+DHA Dosage and Administration

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

How is Vitafol-OB+DHA Supplied

VITAFOL®-OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 caplets and 5 softgel capsules each), (0642-0076-30) and as professional samples (0642-0076-03).

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

Rx

Manufactured for:
EVERETT LABORATORIES, INC.
Chatham, NJ 07928

1-877-324-9349

U.S. Patent No. 6,814,983; 7,390,509
Vitafol® is a trademark of Everett Laboratories, Inc.
Life's DHA™ is a trademark of DSM. U.S. Patent No. 7,163,811: 8,617,617

(Rev. 05/14)

PRINCIPAL DISPLAY PANEL - Kit Carton

0642-0076-30

Vitafol®-OB+DHA

Prenatal Supplement with DHA

SUGAR, LACTOSE, GLUTEN AND IODINE FREE

New
Smaller DHA Softgel

DOES NOT CONTAIN
FISH OIL

life's DHA
HEALTHY BRAIN, EYES, HEART

Rx

Unit Dose Pack
30 Caplets and 30 Softgel Capsules

U.S. Patented

VITAFOL-OB PLUS DHA  PRENATAL SUPPLEMENT PLUS DHA
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, copper, and doconexent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0076
Packaging
# Item Code Package Description
1 NDC:0642-0076-30 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOX 30 
Part 2 1 BOX 30 
Part 1 of 2
VITAFOL-OB 
vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tablet, coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 2700 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 70 mg
Vitamin D (Cholecalciferol) Vitamin D 400 [iU]
.Alpha.-Tocopherol (.Alpha.-Tocopherol) .Alpha.-Tocopherol 30 [iU]
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.6 mg
Riboflavin (Riboflavin) Riboflavin 1.8 mg
Niacin (Niacin) Niacin 18 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 2.5 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Calcium (Calcium) Calcium 100 mg
Iron (Iron) Iron 65 mg
Magnesium (Magnesium) Magnesium 25 mg
Zinc (Zinc) Zinc 25 mg
Copper (Copper) Copper 2 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Stearic Acid  
Croscarmellose Sodium  
Gelatin  
Calcium Phosphate, Dibasic, Anhydrous  
Silicon Dioxide  
Modified Corn Starch (1-Octenyl Succinic Anhydride)  
Sucrose  
Starch, Corn  
Sodium Ascorbate  
Tocopherol  
Magnesium Stearate  
Titanium Dioxide  
Acacia  
Polyethylene Glycols  
Medium-Chain Triglycerides  
Sorbic Acid  
Tricalcium Phosphate  
Hypromelloses  
Polydextrose  
Triacetin  
Hydroxypropyl Cellulose (Type H)  
FD&C Blue No. 1  
FD&C Blue No. 2  
D&C Yellow No. 10  
Aluminum Oxide  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code EV;0079
Contains         
Packaging
# Item Code Package Description
1 30 TABLET, COATED in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/16/2007
Part 2 of 2
DHA 
doconexent capsule
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
GELATIN  
WATER  
Product Characteristics
Color YELLOW (Amber) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 30 CAPSULE in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 02/16/2007
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/16/2007
Labeler - Everett Laboratories, Inc. (071170534)
Revised: 09/2014
 
Everett Laboratories, Inc.
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