Vitafol-OB Caplet

Basic Information

Product Label

Product label for Vitafol-OB Caplet
Full Name: Vitafol-OB Caplet
Brand: Exeltis USA none
Product Type: Multi-Vitamin and Mineral (MVM)
Physical State: Other (e.g. tea bag)
Status: Off Market
Product Version Code: 0763001-01

Contact Information

Distributed by

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

Product Details

Net Contents

N/A(0 Not Present)

Serving Sizes

Unit:Caplet(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Group: Vitamin A

Beta-Carotene is a red-orange pigment found in plants and fruits, especially carrots and colorful vegetables. It is a precursor of vitamin A and is known for its antioxidant properties, playing a crucial role in maintaining skin health and vision.

Also known as: Betatene, Vitamin A

UNII Code: 01YAE03M7J

CalcIum

mineral

Group: Calcium

COPPER

mineral

Group: Copper

Group: Calcium

UNII Code: L11K75P92J

Group: Vitamin E

UNII Code: 7QWA1RIO01

Group: Color

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Glyceryl Triacetate

non-nutrient/non-botanical

Group: Triacetin

Also known as: Triacetin

HPMC

other

Group: Hypromellose

Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose

Group: Collagen

Hydrolyzed collagen is a form of collagen that has been broken down into smaller peptides, ensuring ease of digestion and absorption in the human body. Collagen is the most abundant protein in the body and is essential for maintaining healthy skin, bones, and connective tissues. Hydrolyzed collagen is often used as a supplement to support skin health, joint health, and overall wellness.

Also known as: Gelatin

Group: Hydrolyzed gelatin

Group: Hypromellose

Group: Hypromellose

Also known as: HPMC

UNII Code: 3NXW29V3WO

Maize Starch

complex carbohydrate

Group: Starch

UNII Code: O8232NY3SJ

MCTs

fat

Group: Medium chain triglycerides (MCT)

Also known as: Medium Chain Triglycerides

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

Group: Cellulose

Group: modified Starch

Niacin

vitamin

Group: Niacin

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

UNII Code: 2679MF687A

PEG

other

Group: Polyethylene glycol

Also known as: Polyethylene Glycol

Group: Polydextrose

Also known as: Litesse

UNII Code: VH2XOU12IE

Group: Polyethylene glycol

Also known as: PEG, Macrogol

UNII Code: 3WJQ0SDW1A

Group: Vitamin B6 (pyridoxine)

Pyridoxine, commonly known as Vitamin B6, is a water-soluble vitamin that plays a critical role in brain health, production of neurotransmitters, and the metabolism of proteins, fats, and carbohydrates. It is essential for the proper functioning of sugars, fats, and proteins in the body and is crucial for the development of the brain and nervous system.

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Riboflavin

vitamin

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B-2, vitamin B2, Vitamin B2, B2, activated B2, B-2, Vit. B2, pure powder B-2

UNII Code: TLM2976OFR

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Sodium Ascorbate

non-nutrient/non-botanical

Group: Sodium Ascorbate

Also known as: Na Ascorbate

UNII Code: S033EH8359

Group: Sodium Benzoate

Also known as: Na Benzoate

UNII Code: OJ245FE5EU

Sorbic Acid

non-nutrient/non-botanical

Group: Sorbic acid

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Sucrose

sugar

Group: Sucrose

UNII Code: C151H8M554

Group: Thiamin

UNII Code: 8K0I04919X

Group: Vitamin E (mixed tocopherols)

Triacetin

non-nutrient/non-botanical

Group: Triacetin

Triacetin, also known as glyceryl triacetate, is a triglyceride derived from the esterification of glycerol with acetic acid. It is commonly used as a plasticizer in the production of many biodegradable polymers, but it also finds diverse applications in flavorings, fragrances, and pharmaceuticals. Triacetin is often included as an additive in food products and supplements to facilitate the mixing of ingredients and improve texture.

Group: Calcium

UNII Code: 91D9GV0Z28

Vitamin A

vitamin

Group: Vitamin A

Also known as: Betatene(R), Betatene, CaroCare, Caromin(R)

UNII Code: 81G40H8B0T

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin

Group: Vitamin B2 (unspecified)

Vitamin B2, also known as Riboflavin, is a vital nutrient that belongs to the vitamin B complex. It plays a crucial role in energy production and the metabolism of fats, drugs, and steroids. Riboflavin is found in foods like eggs, green vegetables, milk, and meat, as well as in fortified foods and supplements.

Also known as: Riboflavin

VITAMIN B6

vitamin

Vitamin D3

vitamin

Group: Vitamin D

Vitamin D3, also known as cholecalciferol, is a fat-soluble vitamin that plays a crucial role in bone health by aiding in the absorption of calcium and phosphorus in the body. It can be produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Additionally, Vitamin D3 is found in dietary supplements and fortified foods to help maintain adequate levels for optimal health.

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Product Statements

General Statements: All Other Content

0642-0076-30

FDA Statement of Identity

Prenatal Supplement with DHA Rx

General Statements: All Other Content

Composition:

Precautions re: Allergies

Contains: Soy.

Formula re: Type

Indications and usage: 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.

Formulation re: Does NOT Contain

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

Precautions re: All Other

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).

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 a Poison Control Center immediately.

Precautions re: All Other

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. Avoid overdosage.

Precautions re: Children

Keep out of the reach of children.

Precautions re: All Other

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.

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 substantially higher than those in Vitafol-OB+DHA.

Precautions re: Allergies

Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.

Suggested/Recommended/Usage/Directions

Dosage and administration: Before, during and after pregnancy, one caplet and one soft-gel capsule daily, or as directed by a physician.

General Statements: All Other Content

How 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).

Storage

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

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

2018 Exeltis USA, Inc. U.S. Patent No. 6,814,983; 7,390,509 Vitafol is a trademark of Exeltis USA, Inc.

General Statements: All Other Content

Rev. November 2018

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