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