Folivane-OB with Ascorbic Acid Precursors

Basic Information

Product Label

Full Name: Folivane-OB with Ascorbic Acid Precursors

Brand: Trigen Laboratories none

Product Type: Multi-Vitamin and Mineral (MVM)

Physical State: Capsule

UPC/SKU: 3 13811 53530 3

Product Version Code: PLR-FOLOB-00001-1 Rev. 12/2021

Contact Information

Manufactured for

Name: Trigen Laboratories, LLC

Address:Alpharetta, GA, 30005

Phone: 1-770-509-4500

Types: Distributor

Product Details

Net Contents

30 Capsule(s)(30 Capsule(s))

Serving Sizes

Unit:Capsule(s)

Quantity:1 - 1

Daily Servings:1 - 1

Target Groups

Pregnant WomenLactating

Servings Per Container

Ingredients & Nutrition

Biotin

vitamin

Amount: 300 mcg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 857%

Group: Biotin

Also known as: Vitamin H, Vitamin B-7, Vitamin B7, d-biotin, S. cerevisiae

UNII Code: 6SO6U10H04

Copper

mineral

Forms:

Copper Sulfate

Amount: 0.8 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 62%

Group: Copper

Folate

vitamin

Amount: 1667 mcg DFE

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 278%

Group: Vitamin B9 (Folate)

Iron

mineral

Forms:

Ferrous Fumarate
Polysaccharide Iron Complex

Amount: 85 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 315%

Group: Iron

Magnesium

mineral

Forms:

Magnesium Sulfate

Amount: 6.9 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 2%

Group: Magnesium

Manganese

mineral

Forms:

Manganese Sulfate

Amount: 1.3 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 50%

Group: Manganese

Niacin

vitamin

Amount: 20 mg NE

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 111%

Group: Niacin

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

UNII Code: 2679MF687A

Pantothenic Acid

vitamin

Forms:

D-Calcium Pantothenate

Amount: 7 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 100%

Group: Vitamin B5 (Pantothenic Acid)

Also known as: Vitamin B5, Vitamin B-5, B5, B-5

UNII Code: 19F5HK2737

Riboflavin

vitamin

Amount: 5 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 313%

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

Thiamine

vitamin

Forms:

Thiamine Mononitrate

Amount: 5 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 357%

Group: Thiamin

Also known as: Vitamin B1, B1, Vitamin B-1, B-1

UNII Code: X66NSO3N35

Vitamin B12

vitamin

Forms:

Cyanocobalamin

Amount: 10 mcg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 357%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin

Forms:

Pyridoxine Hydrochloride

Amount: 25 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 1250%

Group: Vitamin B6

Vitamin C

vitamin

Forms:

Ascorbic Acid

Amount: 210 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 175%

Group: Vitamin C (unspecified)

Zinc

mineral

Forms:

Zinc Sulfate

Amount: 18.2 mg

Serving Size: 1 Capsule(s)

Pregnant and Lactating: 140%

Group: Zinc

Allura Red

other

Group: Color

Also known as: E129 FD&C Red No. 40, FD&C Red #40

Brilliant Blue

other

Group: Color

Also known as: FD&C Blue #1

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

HPMC

other

Group: Hypromellose

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

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

organic Pyridoxine

vitamin

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Vit. B1

vitamin

Group: Vitamin B1 (unspecified)

Also known as: Thiamine

Vit. B2

vitamin

Group: Vitamin B2 (unspecified)

Also known as: Riboflavin

Vit. B5

vitamin

Group: Vitamin B5 (unspecified)

Also known as: Pantothenic Acid

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Vitamin H

vitamin

Group: Vitamin B7 (biotin)

Also known as: Biotin

UNII Code: 6SO6U10H04

Product Statements

Formulation re: Other

Description: Folivane-OB are blue opaque capsules imprinted with "T535" in white ink on both cap and body.

Suggested/Recommended/Usage/Directions

Directions for Use One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.

Precautions re: All Other

Do not exceed recommended dosage.

Storage

Storage: Store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F), excursion permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F ) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

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.

FDA Statement of Identity

Prenatal Multivitamin Supplement

Formulation re: Other

Folivane - OB is a prescription prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Folivane - OB may also be used to improve the nutritional status of women.

Precautions re: Children

Do not administer to children under the age of 12.

Precautions re: All Other

Contraindications Folivane - OB is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemia. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.