OB Complete 400

Manufacturer
Vertical Pharmaceuticals Inc.
Effective date
2013-07-01
Label type
DIETARY SUPPLEMENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:40:25

Label at a glance#

ProductOB Complete 400
Active ingredientFish Oil, Doconexent, Omega-3 Fatty Acids, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Folic Acid, Cholecalciferol, Calcium Ascorbate, Calcium Threonate, .ALPHA.-TOCOPHEROL, D-, Niacin, Cupric Sulfate Anhydrous, Zinc Oxide, IRON PENTACARBONYL, Ferrous Asparto Glycinate
Label structure12 sections

Indications and uses

OB Complete™ 400 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.

Dosage and administration

One softgel daily or as prescribed by a physician.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

SUPPLEMENT FACTS
Serving Size: 1 Softgel Capsule
Servings Per Box: 30
For Pregnant and
Lactating Women
Amount per Serving% Daily Value
Purified Fish Oil * 400 mg†
  Docosahexaenoic Acid (DHA)320 mg†
  Other Omegas (as EPA, ALA and Linoleic Acid)40 mg†
Vitamin B1 (Thiamine Mononitrate)2 mg118%
Vitamin B2 (Riboflavin)3.4 mg170%
Vitamin B6 (Pyridoxine HCl)40 mg1600%
Vitamin B12 (Cyanocobalamin)20 mcg250%
Folic Acid1 mg125%
Vitamin D3 (Cholecalciferol)1000 IU250%
Vitamin C (Calcium ascorbate and calcium threonate)110 mg183%
Vitamin E30 IU100%
Vitamin B3 (Niacin)10 mg50%
Copper (Sulfate)1 mg50%
Zinc (Zinc Oxide)25 mg167%
Ferronyl Iron40 mg222%
Sumalate®(Elemental Iron)‡10 mg56%

* Eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA) ratio is approximately 1:16 and are derived from purified fish oils.

† Daily Value has not been established

STATEMENT OF IDENTITY SECTION

Other Ingredients: Gelatin, Purified Water, Yellow Bees Wax, Vanillin, Glycerin, Titanium Dioxide, FD&C Red #40, FD&C Blue #1

INDICATIONS AND USAGE

HEALTH CLAIM SECTION

OB Complete™ 400 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.

CONTRAINDICATIONS

HEALTH CLAIM SECTION

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

PRECAUTIONS

PRECAUTIONS SECTION

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

WARNINGS SECTION

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 yrs. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

DRUG INTERACTIONS

PRECAUTIONS SECTION

OB Complete™ 400 softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.

ADVERSE REACTIONS

PRECAUTIONS SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

One softgel daily or as prescribed by a physician.

DESCRIPTION

STATEMENT OF IDENTITY SECTION

OB Complete™ 400 are pink color soft gelatin capsules, imprinted "VP048".

HOW SUPPLIED

SAFE HANDLING WARNING SECTION

OB Complete™ 400 is available in carton unit dose pack of 30 (3 child resistant blister cards of 10 softgels per card). Product Code 68025-048-30.

STORAGE

SAFE HANDLING WARNING SECTION

Store at controlled room temperature 15°-30°C (59°-86°F) [See USP] Protect from light, moisture and excessive heat.

‡ Sumalate® (ferrous asparto glycinate) is a registered trademark of Albion International, Inc., Clearfield, Utah

U.S. Pat. No. 6,716,814; U.S. Pat. No. 5,516,925; and U.S. Pat. No. 8,007,846 and patents pending (including: U.S. Pat. Appl. No. 13/189,893 and U.S. Pat. Appl. No. 61/538,028)

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN

Rx Only

Call your doctor about side effects. You may report side effects by calling 877-95-VERTI (877-958-3784).

Manufactured for: Vertical Pharmaceuticals Inc.
Sayreville, NJ 08872
www.verticalpharma.com

Rev. 03/2013

PRINCIPAL DISPLAY PANEL - 30 Softgel Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OB
complete™
400

Prenatal
Multivitamin
with DHA

30
SOFTGELS

Rx Only

Provides Complete Supplemental Nutrition for You and
Your Baby Before, During and After Pregnancy

68025-048-30

VERTICAL
PHARMACEUTICALS, INC.

US Patent No. 6,716,814
5,516,925
8,007,846

Principal Display Panel - 30 Softgel Carton
Principal Display Panel - 30 Softgel Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68025-048-30EA - Each68025-04829533bd4-0e66-41d5-90e2-05034028ac3b12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL, D-ACTIVE INGREDIENTN9PR3490H91
Calcium AscorbateACTIVE INGREDIENT183E4W213W1
Calcium ThreonateACTIVE INGREDIENTHBB4YPO93U1
CholecalciferolACTIVE INGREDIENT1C6V77QF411
Cupric Sulfate AnhydrousACTIVE INGREDIENTKUW2Q3U1VV1
CyanocobalaminACTIVE INGREDIENTP6YC3EG2041
DoconexentACTIVE INGREDIENTZAD9OKH9JC1
Ferrous Asparto GlycinateACTIVE INGREDIENTH7426RGB3L1
Fish OilACTIVE INGREDIENTXGF7L72M0F1
Folic AcidACTIVE INGREDIENT935E97BOY81
IRON PENTACARBONYLACTIVE INGREDIENT6WQ62TAQ6Z1
NiacinACTIVE INGREDIENT2679MF687A1
Omega-3 Fatty AcidsACTIVE INGREDIENT71M78END5S1
Pyridoxine HydrochlorideACTIVE INGREDIENT68Y4CF58BV1
RiboflavinACTIVE INGREDIENTTLM2976OFR1
Thiamine MononitrateACTIVE INGREDIENT8K0I04919X1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H91
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R1
Calcium cationACTIVE MOIETY2M83C4R6ZB1
CholecalciferolACTIVE MOIETY1C6V77QF411
Cupric CationACTIVE MOIETY8CBV67279L1
CyanocobalaminACTIVE MOIETYP6YC3EG2041
DoconexentACTIVE MOIETYZAD9OKH9JC1
Ferrous CationACTIVE MOIETYGW89581OWR1
Fish OilACTIVE MOIETYXGF7L72M0F1
Folic AcidACTIVE MOIETY935E97BOY81
NiacinACTIVE MOIETY2679MF687A1
Omega-3 Fatty AcidsACTIVE MOIETY71M78END5S1
PyridoxineACTIVE MOIETYKV2JZ1BI6Z1
RiboflavinACTIVE MOIETYTLM2976OFR1
Thiamine IonACTIVE MOIETY4ABT0J945J1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Ethyl VanillinINACTIVE INGREDIENTYC9ST449YJ1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOA1
GelatinINACTIVE INGREDIENT2G86QN327L1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
WaterINACTIVE INGREDIENT059QF0KO0R1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68025-04868025-048-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 238 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GelatinGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
GelatinGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
GelatinGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
GelatinGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Red No. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Blue No. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GelatinGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmegavenFISH OILFresenius Kabi USA, LLC5d9d0b24-e139-48bf-ab2d-536fb59cf8e02025-09-05Warnings, Adverse reactionsName fallback
generic name: FISH OIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.