ELITE OB PRENATAL MULTIVITAMIN- vitamin a, thiamine, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, vitamin d, ascorbic acid, .alpha.-tocopherol succinate, d-, niacinamide, pantothenic acid, copper, magnesium oxide, zinc oxide and iron tablet 
TRIGEN Laboratories, Inc.

----------

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

Principal Display Panel - 100 Tablets Label
ELITE OB  PRENATAL MULTIVITAMIN
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 TypeItem Code (Source)NDC:13811-027
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (VITAMIN A) VITAMIN A2100 [iU]
THIAMINE (THIAMINE ION) THIAMINE2 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN3.40 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN15 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID1.25 mg
VITAMIN D (CHOLECALCIFEROL) VITAMIN D315 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID120 mg
.ALPHA.-TOCOPHEROL SUCCINATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL SUCCINATE, D-20 [iU]
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE10 mg
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID5 mg
COPPER (COPPER) COPPER1 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE15 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE10 mg
Iron (Iron) Iron50 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeCAPSULE (capsule shaped caplet) Size19mm
FlavorImprint Code TL001
Contains    
Packaging
#Item CodePackage Description
1NDC:13811-027-1010 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT07/13/2013
Labeler - TRIGEN Laboratories, Inc. (830479668)
Establishment
NameAddressID/FEIBusiness Operations
VIVA PHARMACEUTICAL INC.253288898manufacture(13811-027)

Revised: 07/2013
Document Id: aa853a28-3a53-4b1c-ba16-cb3479e14b9e
Set id: 6aead698-0370-4d05-9e22-61b9ea5f6b61
Version: 1
Effective Time: 20130713
 
TRIGEN Laboratories, Inc.