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Elite OB

TRIGEN Laboratories, Inc.

Elite OB


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION:

Elite OBTM is a pink capsule shaped caplet multivitamin/multimineral embossed on one side "TL001".

Supplement Facts
Servings per Carton: 100
Serving Size: 1 Caplet
Each caplet contains
%DV for Pregnant and
Lactating Women
Vitamin A(beta carotene)..... ....... 2100 IU ........ 26%
Vitamin B1 (thiamine mononitrate)...... ....... 2 mg ...... 118%
Vitamin B2 (riboflavin)...... ....... 3.40 mg ...... 200%
Vitamin B6 (pyridoxine HCL)...... ....... 10 mg ...... 400%
Vitamin B12 (cyanocobalamin)...... ....... 15 mcg ...... 186%
Folic Acid ....... 1.25 mg ...... 156%
Vitamin D (cholecalciferol)...... ....... 315 IU ...... 79%
Vitamin C (ascorbic acid)...... ....... 120 mg ...... 200%
Vitamin E (d-alpha succinate)...... .......20 IU ...... 67%
Niacin (niacinamide)...... .......10 mg ...... 50%
Pantothenic Acid ....... 5 mg ...... 50%
Copper (gluconate)...... ....... 1 mg ...... 50%
Magnesium (magnesium oxide)...... ....... 15 mg ...... 4%
Zinc (zinc oxide)...... ....... 10 mg ...... 67%
Iron (ferronyl, micronised)...... ....... 50 mg ...... 278%

Inactive Ingredients:

Microcrystalline Cellulose, Di Calcium Phosphate, Croscarmellose Sodium, Hypromellose, Titanium Dioxide, Fumed Silica, Stearic Acid, Magnesium Stearate, Povidone K30, Acacia, Polyethylene Glycol, Ethyl Cellulose, Talc, Polysorbate 80, Mineral Oil, FD&C Red #40 Lake.

INDICATIONS:

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

CONTRAINDICATIONS:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTION:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other meagloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that heamtologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parentral administration of folic acid.

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.

DOSAGE AND ADMINISTRATION:

One caplet daily or as prescribed by a physician

HOW SUPPLIED

Elite OBTMis available as a pink capsule shaped caplet. Available in unit-dose pack of 100 (10x10)

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Avoid excessive heat.

Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).

PRODUCT CODE: 13811-027-10.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

Rx Only

Manufactured for:
TRIGEN Laboratories, Inc. Sayreville, NJ 08872
www.trigenlab.com

Rev. 06/13

PRINCIPAL DISPLAY PANEL - 100 tablet label

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

13811-027-10
Rx Only

Elite OBTM

Prenatal
Multivitamin

TRIGEN
LABORATORIES

Elite OB

Elite OB

beta carotene, thiamine mononitrate, riboflavin, pyridoxine HCl, cyanocobalamin, Folic Acid, cholecalciferol, ascorbic acid, d-alpha succinate, niacinamide, pantothenic acid,gluconate, magnesium oxide, zinc oxide and ferronyl, micronised TABLET

Product Information

Product Type Dietary supplement Item Code (Source) NDC:13811-027
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A 2100 [iU]
Thiamine 2 mg
RIBOFLAVIN RIBOFLAVIN 3.40 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 10 mg
Cyanocobalamin CYANOCOBALAMIN 15 ug
FOLIC ACID FOLIC ACID 1.25 mg
Vitamin D 315 [iU]
ASCORBIC ACID ASCORBIC ACID 120 mg
.ALPHA.-TOCOPHEROL SUCCINATE, D- 20 [iU]
NIACINAMIDE 10 mg
PANTOTHENIC ACID 5 mg
Copper COPPER 1 mg
magnesium oxide 15 mg
Zinc Oxide Zinc oxide 10 mg
IRON IRON 50 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CROSCARMELLOSE SODIUM
HYPROMELLOSES
titanium dioxide
SILICON DIOXIDE
STEARIC ACID
MAGNESIUM STEARATE
POVIDONE K30
ACACIA
POLYETHYLENE GLYCOLS
ETHYLCELLULOSES
talc
polysorbate 80
Mineral Oil
FD&C RED NO. 40

Product Characteristics

Color Size Imprint Code Shape
PINK 19 mm TL001 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13811-027-10 10 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-07-13


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