Obstetrix EC

Manufacturer
Seyer Pharmatec, Inc.
Effective date
2023-02-14
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:40

Label at a glance#

ProductObstetrix EC
Active ingredientBETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, IRON, MAGNESIUM OXIDE, ZINC OXIDE, SODIUM SELENATE
Label structure7 sections

Dosage and administration

One caplet daily or as directed by a physician. CONTRAINDICATIONS: OBSTETRIX™ EC is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

 Supplement Facts
 Serving Size: 1 Caplet / Servings Per Container: 60
Amount% Daily
Per ServingValue**
 Vitamin A (as Beta Carotene)810 mcg 62% 
 Vitamin C (as Ascorbic Acid)120 mg 100% 
 Vitamin D (as Cholecalciferol)10 mcg 67% 
 Vitamin E (as dl-Alpha Tocopheryl Acetate)8.1 mg 43% 
 Thiamin (as Thiamine HCl)3 mg 214% 
 Riboflavin3.4 mg 213% 
 Niacin (as Niacinamide)20 mg 111% 
 Vitamin B6 (as Pyridoxine HCl)40 mg 2000% 
 Folate (as L-5-Methyltetrahydrofolate Calcium)1700 mcg DFE 283% 
(1000 mcg Folic Acid) 
 Vitamin B12 (as Cyanocobalamin)12 mcg 429% 
 Iron (as Carbonyl Iron)29 mg 107% 
 Magnesium (as Magnesium Oxide)30 mg 8% 
 Zinc (as Zinc Oxide)25 mg 192% 
 Selenium (as Sodium Selenate)65mcg 93% 
 * Daily Value (DV) for Pregnant and Lactating Women.

OTHER INGREDIENTS:

Microcrystalline Cellulose, Methacrylic Acid Copolymer, Croscarmellose Sodium, Gelatin, Stearic Acid, Hypromellose, Maltodextrin, Crospovidone, Starch, Silica, Titanium Dioxide, Triacetin, Sucrose, Citric Acid, Magnesium Stearate, Sodium Lauryl Sulfate, Polyvinylpyrrolidone, Soy Polysaccharide, Mineral Oil, Riboflavin, FD&C Yellow #6 Lake, Sodium Ascorbate, Polyethylene Glycol, Trisodium Citrate, Tocopherols, Tricalcium Phosphate, Glycerol Monostearate, Triethyl Citrate, Ascorbyl Palmitate, Triglycerides, Sodium Benzoate, Polysorbate 80, Sorbic Acid and Talc. Contains soy.

DESCRIPTION:

OBSTETRIX™ EC enteric coated prenatal caplets are a multivitamin/multi-mineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers.†

It is recommended that for all women folate levels should be high for at least one month prior to possible conception and continued at that level for the first three months of pregnancy.†

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

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

One caplet daily or as directed by a physician.

CONTRAINDICATIONS:

OBSTETRIX™ EC is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

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 the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B-12 is deficient.

PRECAUTIONS:

PRECAUTIONS SECTION

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

ADVERSE REACTIONS:

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

STORAGE:

SAFE HANDLING WARNING SECTION

Store at room temperature, USP.

Keep out of the reach of Children.

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

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

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

HEALTH CLAIM SECTION

Dietary Supplement

Enteric Coated Prenatal Caplets

with 100% Bioactive Folate

• Well tolerated
• Easy to swallow

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Obstetrix3Obstetrix3

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
11026-2632-6Obstetrix EC60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11026-2632OBSTETRIX EC (BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, DL-ALPHA TOCOPHERYL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, L-5-METHYLTETRAHYDROFOLATE CALCIUM, CYANOCOBALAMIN, CARBONYL IRON, MAGNESIUM OXIDE, ZINC OXIDE, SODIUM SELENATE) TABLET [SEYER PHARMATEC, INC.]11 package rows20230224_a2506c4b-63d2-4b55-930e-15f74c1637cc.zip

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11026-263211026-2632-6

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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