Elite OB

Basic Information

Product Label

Product label for Elite OB
Full Name: Elite OB
Brand: Trigen Laboratories none
Product Type: Multi-Vitamin and Mineral (MVM)
Physical State: Other (e.g. tea bag)
UPC/SKU: 3 13811 02710 5
Product Version Code: PLR-EOB-00002-1 Rev. 12/2021

Contact Information

Manufactured for

Name: Trigen Laboratories, LLC
Address:Alpharetta, GA, 30005
Website: www.trigenlab.com
Types: Distributor

Product Details

Net Contents

100 Caplet(s)(100 Caplet(s))

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)LactatingGluten FreeSugar Free

Servings Per Container

100

Ingredients & Nutrition

Copper

mineral
Forms:
  • Copper Gluconate
Amount: 1 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 77%

Group: Copper

Folate

vitamin
Amount: 2083 mcg DFE
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 347%

Group: Vitamin B9 (Folate)

Iron

mineral
Forms:
  • Ferronyl Carbonyl Iron
Amount: 50 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 185%

Group: Iron

Magnesium

mineral
Forms:
  • Magnesium Oxide
Amount: 15 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 4%

Group: Magnesium

Niacin

vitamin
Forms:
  • Niacinamide
Amount: 10 mg NE
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 56%

Group: Niacin

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

UNII Code: 2679MF687A

Amount: 5 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 71%

Group: Vitamin B5 (Pantothenic Acid)

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

UNII Code: 19F5HK2737

Riboflavin

vitamin
Amount: 3.4 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 213%

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: 2 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 143%

Group: Thiamin

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

UNII Code: X66NSO3N35

Vitamin A

vitamin

Notes: 2100 IU

Forms:
  • Beta-Carotene
Amount: 630 mcg RAE
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 48%

Group: Vitamin A (unspecified)

Forms:
  • Cyanocobalamin
Amount: 15 mcg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 536%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin
Forms:
  • Pyridoxine Hydrochloride
Amount: 10 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 500%

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 120 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 100%

Group: Vitamin C (unspecified)

Vitamin D

vitamin

Notes: 315 IU

Forms:
  • Cholecalciferol
Amount: 8 mcg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 53%

Group: Vitamin D

Vitamin E

vitamin

Notes: 20 IU, equal to mg alpha-tocopherol

Forms:
  • D-Alpha-Tocopheryl Succinate
Amount: 13 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 68%

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: 10 mg
Serving Size: 1 Caplet(s)
Pregnant and Lactating: 77%

Group: Zinc

Acacia

botanical

Group: Acacia

Also known as: Gum Arabic

UNII Code: 5C5403N26O

Group: Vitamin A

Also known as: Betatene, Vitamin A

UNII Code: 01YAE03M7J

Group: Croscarmellose Sodium

Group: Calcium

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

Group: Fumed Silica

Group: Acacia

Also known as: Acacia

Group: Magnesium stearate

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Group: Cellulose

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Group: Coating

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

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

Product Statements

Formulation re: Does NOT Contain

Gluten, sugar, and lactose-free

Formula re: Type

Elite OB is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.

Precautions re: Allergies

Contraindications Elite OB should not be used by patients with a known hypersensitivity to any of the listed ingredients.

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

Precautions Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Precautions re: Allergies

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Precautions re: Pregnant or Nursing or Prescription Medications

The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. Drug Interactions Elite OB caplets are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

Precautions re: All Other

Adverse Reactions Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Precautions re: Allergies

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels.

General Statements: All Other Content

Description Elite OB is a pink capsule shaped caplet imprinted with "VP 010".

Suggested/Recommended/Usage/Directions

Directions For Use Take one caplet by mouth daily or as directed by a physician.

General Statements: All Other Content

How Supplied Elite OB is available in a unit dose pack of 100 (10x10) caplets. Product Code: 13811-027-10

Storage

Storage Store at controlled room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F). [See USP]. Protect from light and moisture and avoid excessive heat.

Precautions re: Children

Keep this product out of reach of children.

General Statements: All Other Content

For use on the order of a healthcare practitioner.

Precautions re: All Other

Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

General Statements: All Other Content

13811-027-10

FDA Statement of Identity

Prenatal Multivitamin

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