Obstetrix ONE

Manufacturer
Seyer Pharmatec, Inc.
Effective date
2024-06-04
Label type
DIETARY SUPPLEMENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:51:05

Label at a glance#

ProductObstetrix ONE
Active ingredientCALCIUM ASCORBATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, MAGNESIUM OXIDE, ZINC OXIDE, DOCONEXENT
Label structure7 sections

Dosage and administration

Take One (1) Softgel Daily with or without food or as recommended by your healthcare provider.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts

Serving Size: 1 Softgel / Servings Per Container: 30

Amount

Per Serving

% Daily

Value**

Vitamin C (as calcium ascorbate dihydrate) 18 mg 15%
Vitamin D (as cholecalciferol) 6.25 mcg 42%
Vitamin E (as d-alpha tocopheryl acetate) 10 mg 53%
Vitamin B6 (as pyridoxine HCl) 30 mg 1500%
Folate (as L-5-methylfolate, calcium salt) -Metafolin® (1mg folate) 1.7 mg DFE 284%
Vitamin B12 (as cyanocobalamin) 15 mcg 536%
Iron (as carbonyl iron) 38 mg 141%
Magnesium (as magnesium oxide) 15 mg 4%
Zinc (as zinc oxide) 20 mg 154%
DHA (Docosahexaenoic Acid from Algal Oil) 225 mg *

* Daily Value not established.

** Daily Value for Pregnant and Lactating Women.

OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, glycerin, purified water, annatto, and sodium copper chlorophyllin), sunflower lecithin, white beeswax.

Metafolin® is a registered trademark of Merck KGaA, Darmstadt Germany.

To report a serious adverse event or to obtain product information, contact (888) 444-5072.

For lot number and expiration date, please see bottom of the box.

Rev.: 03/24   Code: SEY2625-30UC 

DESCRIPTION: OBSTETRIX ONE is a premium prenatal vitamin and mineral supplement with DHA taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers. OBSTETRIX ONE is also useful in improving nutritional status prior to conception. It is recommended that folate levels be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy. †

WARNINGS SECTION

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.

DO NOT USE OBSTETRIX ONE if you have a known hypersensitivity to any of the ingredients within. This product is not intended for children under 12 years of age. 

WARNING: Ingestion of more than 3 grams per day of Omega-3 fatty acids, such as DHA (docosahexaenoic acid) has been shown to have potential anti-thrombotic effects, including increased bleeding times. Talk to your doctor if you are concerned about the effects of the DHA in OBSTETRIX ONE especially if you are taking anticoagulants.

CAUTION:

PRECAUTIONS SECTION

This product contains 1.7mg DFE (1mg) folic acid, the maximum safe Reference Daily Intake (RDI) amount for this nutrient. Folic Acid alone should not be used for individuals with pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in amounts 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.

ADDITIONAL INFORMATION: Potential discoloration and/or darkening on soft gels or soft gel seams may occur immediately or over time, due to the Vitamin C and Iron. This does not affect product efficacy and is merely cosmetic.

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

DIRECTIONS FOR USE:

DOSAGE & ADMINISTRATION SECTION

Take One (1) Softgel Daily with or without food or as recommended by your healthcare provider.

OTHER INFORMATION:

SAFE HANDLING WARNING SECTION

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from extreme temperatures. Freezing & excessive heat may damage softgels.

 † These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

HEALTH CLAIM SECTION

Dietary Supplement

PREMIUM PRENATAL MULTI-VITAMIN WITH DHA

with 100% Bioactive Folate

NO ARTIFICIAL COLORANTS OR DYES

FINALLY, A PRENATAL YOU CAN STOMACH!

PRODUCT BENEFITS

Metafolin® - increases plasma folate more effectively than folic acid

Carbonyl Iron – slow release, 98% pure, high bioavailability

Plant based DHA – no fishy ‘burp backs’

Vitamin B6 – to help relieve morning sickness and minimize fatigue

Non-constipating formula – changing hormone levels in early pregnancy cause constipation

Small Softgel — easy to swallow, reduces gag reflex

OBSTETRIX ONE was specifically formulated to help reduce some of the unpleasant side effects associated with pregnancy and prenatal vitamin supplementation, while providing the latest in prenatal nutrition.

Manufactured in the USA for:
Seyer Pharmatec, Inc.
Caguas, Puerto Rico 00725

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Seyer-2630Seyer-2630

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11026-2630-3Obstetrix ONE30 in 1 BOTTLECAPSULE, GELATIN COATED302
11026-2630-5Obstetrix ONE10 in 1 BLISTER PACKCAPSULE, GELATIN COATED102
11026-2630-5Obstetrix ONE3 in 1 BOXCAPSULE, GELATIN COATED32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11026-2630OBSTETRIX ONE (CALCIUM ASCORBATE DIHYDRATE, CHOLECALCIFEROL, D-ALPHA TOCOPHERYL ACETATE, PYRIDOXINE HYDROCHLORIDE, CALCIUM L-5-METHYLTETRAHYDROFOLATE, CYANOCOBALAMIN, CARBONYL IRON, MAGNESIUM OXIDE, ZINC OXIDE, DOCOSAHEXAENOIC ACID) CAPSULE, GELATIN COATED [SEYER PHARMATEC, INC.]23 package rows20240614_5e34e3d7-74f6-4e56-8a48-e6ed886f5aff.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11026-263011026-2630-3, 11026-2630-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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