Trinatal Ultra Tablets

Basic Information

Product Label

Full Name: Trinatal Ultra Tablets

Brand: Trigen Laboratories none

Product Type: Other Combinations

Physical State: Tablet or Pill

UPC/SKU: 3 13811 61510 4

Product Version Code: Rev 05/13

Contact Information

Manufactured for

Name: Trigen Laboratories, LLC

Address:Sayreville, NJ, 08872

Website: www.trigenlab.com

Types: Distributor

Product Details

Net Contents

100 Tablet(s)(100 Tablet(s))

Serving Sizes

Unit:Tablet(s)

Quantity:1 - 1

Daily Servings:1 - 1

Target Groups

Adult (18 - 50 Years)

Servings Per Container

100

Ingredients & Nutrition

Calcium

mineral

Forms:

Calcium Citrate

Amount: 200 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 15%

Group: Calcium

Copper

mineral

Forms:

Cupric Oxide

Amount: 2 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 100%

Group: Copper

Docusate Sodium

non-nutrient/non-botanical

Amount: 50 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 3%

Group: Docusate Sodium

Folic Acid

vitamin

Amount: 1 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 125%

Group: Folate

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

UNII Code: 935E97BOY8

Iodine

mineral

Forms:

Potassium Iodide

Amount: 150 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 100%

Group: Iodine

Iron

mineral

Notes: Elemental

Forms:

Carbonyl Iron

Amount: 90 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 500%

Group: Iron

Niacinamide

vitamin

Amount: 20 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 100%

Group: Niacin

Also known as: Vitamin B3, B3

UNII Code: 25X51I8RD4

Vitamin A

vitamin

Forms:

Beta-Carotene
Vitamin A Palmitate

Amount: 2700 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 34%

Group: Vitamin A (unspecified)

Vitamin B1

vitamin

Forms:

Thiamine Mononitrate

Amount: 3 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 176%

Group: Thiamin

Also known as: Thiamin, Thiamine

UNII Code: X66NSO3N35

Vitamin B12

vitamin

Forms:

Cyanocobalamin

Amount: 12 mcg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 150%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B2

vitamin

Forms:

Riboflavin

Amount: 3.4 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 170%

Group: Vitamin B

Vitamin B6

vitamin

Forms:

Pyridoxine Hydrochloride

Amount: 20 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 800%

Group: Vitamin B6

Vitamin C

vitamin

Forms:

Ascorbic Acid

Amount: 120 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 200%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin

Forms:

Cholecalciferol

Amount: 400 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 100%

Group: Vitamin D

Also known as: Cholecalciferol, Vitashine vegan Cholecaciferol, Vitashine, Vitashine D3 Cholecalciferol, Vitashine vegan Cholecalciferol, natural Cholecalciferol, plant-based Cholecalciferol, vegan Cholecalciferol, fermented Cholecalciferol, Vitashine D3

UNII Code: 1C6V77QF41

Vitamin E

vitamin

Forms:

DL-Alpha-Tocopheryl Acetate

Amount: 30 IU

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 100%

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Zinc

mineral

Forms:

Zinc Oxide

Amount: 25 mg

Serving Size: 1 Tablet(s)

Adults and children 4 or more years of age: 167%

Group: Zinc

Acacia

botanical

Group: Acacia

Also known as: Gum Arabic

UNII Code: 5C5403N26O

Beta-Carotene

vitamin

Group: Vitamin A

Also known as: Betatene, Vitamin A

UNII Code: 01YAE03M7J

Cholecalciferol

vitamin

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Citric Acid

non-nutrient/non-botanical

Group: Citric Acid

Croscarmellose Sodium

other

Group: Croscarmellose Sodium

DSS

non-nutrient/non-botanical

Group: Docusate Sodium

Also known as: Docusate Sodium

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

fumed Silica

other

Group: Fumed Silica

Gum Arabic, Powder

botanical

Group: Acacia

Also known as: Acacia

HPMC

other

Group: Hypromellose

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

Hypromellose

other

Group: Hypromellose

Magnesium Stearate

other

Group: Magnesium stearate

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Microcrystalline Cellulose

other

Group: Cellulose

organic Pyridoxine

vitamin

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

organic Riboflavin

vitamin

Group: Vitamin B2 (Riboflavin)

Also known as: Vitamin B2

organic Thiamine

vitamin

Group: Vitamin B1 (Thiamine)

Also known as: Vitamin B1

PEG

other

Group: Polyethylene glycol

Also known as: Polyethylene Glycol

Polyethylene Glycol

other

Group: Polyethylene glycol

Also known as: PEG

Polyvinyl Alcohol

other

Group: Polyvinyl alcohol

Povidone K30

other

Group: Povidone

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Talc

other

Group: Magnesium Silicate

Titanium Dioxide

other

Group: Titanium Dioxide

Tripotassium Citrate

non-nutrient/non-botanical

Group: Potassium Citrate

UNII Code: 86R1NVR0HW

Product Statements

Suggested/Recommended/Usage/Directions

Recommended Use Usual dosage is one (1) tablet daily or as prescribed by a physician.

Storage

Storage: Store at 20 degrees -25 degrees C (68 degrees -77 degrees F), excursions permitted to 15 degrees -30 degrees C (59 degrees -86 degrees F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet.

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.

Precautions re: All Other

Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Precautions re: Children

Keep out of the reach of children.

General Statements: All Other Content

All prescriptions using this product shall be pursuant to state statuses as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

General Statements: All Other Content

Rx Only

Formulation re: Other

Description Trinatal Ultra is a prescription prenatal multivitamin/multimineral tablet which contains calcium citrate and carbonyl iron. Each dye-free, oil-and-water soluble, white tablet is debssed "TL615".