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

  • NDC Code(s): 13811-027-10
  • Packager: Trigen Laboratories, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 30, 2018

If you are a consumer or patient please visit this version.

  • SUPPLEMENT FACTS

    Elite OB Supplement Facts Table

    Other Ingredients: Microcrystalline Cellulose, Di Cal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Povidone K30, Acacia.

    GLUTEN, SUGAR, AND LACTOSE FREE

    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.

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  • CONTRAINDICATIONS

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

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  • WARNINGS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
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  • 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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

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  • 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).

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  • 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.

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  • DESCRIPTION

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

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  • DIRECTIONS FOR USE

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

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  • HOW SUPPLIED

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

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  • STORAGE

    Store at controlled room temperature 15º-30ºC (59º-86ºF). [See USP]. Protect from light and moisture and avoid excessive heat.

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  • PRECAUTIONS

    KEEP OUT OF REACH OF CHILDREN.

    For use on the order of a healthcare practitioner.

    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.

                                                                                                                                                                                                                                     Rev. 08/2018

    Customer Service: 1-888-987-4436

    Manufactured for:

    Trigen Laboratories, LLC

    Bridgewater, NJ 08807

    www.trigenlab.com

    Trigen Logo
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  • PRINCIPAL DISPLAY PANEL - 100 tablet label

    13811-027-10

    Elite OBTM

    Prenatal
    Multivitamin

    TRIGEN
    LABORATORIES

    Elite OB Carton

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  • INGREDIENTS AND APPEARANCE
    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 Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-027
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2100 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 2 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.40 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 10 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 15 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.25 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D 315 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D- 20 [iU]
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 10 mg
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 5 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 1 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 15 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    ACACIA (UNII: 5C5403N26O)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    TALC (UNII: 7SEV7J4R1U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-027-10 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 07/13/2013
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    imprint
    scoring 1
    shape
    size (solid drugs) 19 mm
    Labeler - Trigen Laboratories, LLC (830479668)
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