Nexa Plus by Vertical Pharmaceuticals, LLC Nexa® Plus Capsules

Nexa Plus by

Drug Labeling and Warnings

Nexa Plus by is a Other medication manufactured, distributed, or labeled by Vertical Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEXA PLUS- ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, biotin, calcium, iron, docusate calcium, and crypthecodinium cohnii dha oil capsule 
Vertical Pharmaceuticals, LLC

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Nexa® Plus Capsules

Rx only

Rx Prenatal Vitamin with Plant-Based DHA from Algal Oil

  • 1.25 mg Folic Acid and 350 mg DHA (key omega-3 fatty acid)
  • Essential vitamins and minerals
  • Gentle stool softener

DESCRIPTION

Nexa® Plus Capsules are a prescription prenatal / postnatal multivitamin / mineral softgel capsule with plant-based DHA. Nexa® Plus Capsules are available as opaque brown, oblong capsules imprinted "0374" and are available in 30-count bottles (NDC: 68025-064-30).

  • * 158 mg calcium from calcium carbonate, USP and 2 mg calcium from docusate calcium, USP
  • Providing 350 mg DHA (docosahexaenoic acid)
  • Each softgel capsule contains:
    Vitamin C (ascorbic acid, USP)28 mg
    Vitamin D3 (cholecalciferol, USP)800 IU
    Vitamin E (d-alpha tocopherol, USP)30 IU
    Vitamin B6 (pyridoxine hydrochloride, USP)25 mg
    Folic Acid, USP1.25 mg
    Biotin250 mcg
    Calcium160 mg*
    Iron (ferrous fumarate, USP)29 mg
    Algal oil blend (derived from Crypthecodinium cohnii)660 mg
    Docusate Calcium, USP55 mg

    Other Ingredients:

    Ascorbyl palmitate, corn oil, ethyl vanillin, FD&C Yellow #6, FD&C Red #40, FD&C Blue #1, gelatin, glycerin, lecithin, soybean oil, sunflower oil, titanium dioxide, water, yellow beeswax, white ink (ammonium hydroxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac glaze in SD-45 alcohol, simethicone, titanium dioxide).

    Contains: Soy

    INDICATIONS

    Nexa® Plus Capsules are indicated to provide vitamin/mineral and plant-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Nexa® Plus may be useful in improving the nutritional status of women prior to conception.

    CONTRAINDICATIONS

    Nexa® Plus Capsules are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

    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.

    WARNING

    Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

    PRECAUTION

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

    ADVERSE REACTIONS

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

    CAUTION

    Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

    DOSAGE AND ADMINISTRATION

    Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

    HOW SUPPLIED

    Nexa® Plus Capsules are available as opaque brown, oblong capsules imprinted "0374" and are available in 30-count bottles (NDC: 68025-064-30).

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784).

    Store at 20° – 25°C (68° – 77° F). [See USP Controlled Room Temperature.]

    Distributed by:
    Vertical Pharmaceuticals, LLC
    Sayreville, NJ 08872
    www.verticalpharma.com
    Customer Service: 1-866-600-4799

    106408-02
    Revised 0414

    © 2014 Vertical Pharmaceuticals, LLC
    All rights reserved.
    US Patent 8,529,979

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    NDC: 68025-064-30
    Rx ONLY

    Daily-Capsule
    Nexa®plus

    Rx Prenatal Vitamin
    with Plant-Based DHA

    ONCE-DAILY
    DHA
    FROM ALGAL OIL

    ESSENTIAL VITAMINS
    AND MINERALS INCLUDING
    BIOTIN, PLUS DHA AND A
    GENTLE STOOL SOFTENER

    30 SOFTGEL CAPSULES

    VERTICAL
    PHARMACEUTICALS, LLC

    Principal Display Panel - 30 Capsule Bottle Label
    NEXA PLUS 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, biotin, calcium, iron, docusate calcium, and crypthecodinium cohnii dha oil capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:68025-064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid28 mg
    cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol800 [iU]
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol30 [iU]
    pyridoxine (UNII: KV2JZ1BI6Z) (pyridoxine - UNII:KV2JZ1BI6Z) pyridoxine25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1.25 mg
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin250 ug
    Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium160 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron29 mg
    Docusate Calcium (UNII: 6K7YS503HC) (Docusate - UNII:M7P27195AG) Docusate Calcium55 mg
    Crypthecodinium cohnii dha oil (UNII: 8ZJ335A17J) (Crypthecodinium cohnii dha oil - UNII:8ZJ335A17J) Crypthecodinium cohnii dha oil660 mg
    Inactive Ingredients
    Ingredient NameStrength
    ascorbyl palmitate (UNII: QN83US2B0N)  
    corn oil (UNII: 8470G57WFM)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    gelatin (UNII: 2G86QN327L)  
    glycerin (UNII: PDC6A3C0OX)  
    egg phospholipids (UNII: 1Z74184RGV)  
    soybean oil (UNII: 241ATL177A)  
    sunflower oil (UNII: 3W1JG795YI)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    water (UNII: 059QF0KO0R)  
    yellow wax (UNII: 2ZA36H0S2V)  
    ammonia (UNII: 5138Q19F1X)  
    isopropyl alcohol (UNII: ND2M416302)  
    butyl alcohol (UNII: 8PJ61P6TS3)  
    propylene glycol (UNII: 6DC9Q167V3)  
    shellac (UNII: 46N107B71O)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:68025-064-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/01/201409/30/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)24 mm
    Labeler - Vertical Pharmaceuticals, LLC (173169017)

    Revised: 9/2019
     
    Vertical Pharmaceuticals, LLC