Obstetrix DHA Combo Pack

Manufacturer
Seyer Pharmatec, Inc.
Effective date
2023-02-10
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:40

Label at a glance#

ProductObstetrix DHA Combo Pack
Active ingredientDOCONEXENT, BETA 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 structure15 sections

Dosage and administration

One softgel daily; before, during and after pregnancy, with or without food, or as directed by a physician.

Label contents#

Full prescribing information#

Obstetrix™ DHA Softgels

STATEMENT OF IDENTITY SECTION

 Supplement Facts
 Serving Size: 1 Softgel / Servings Per Container: 30
Amount % Daily
Per ServingValue 
 DHA (docosahexaenoic acid)350 mg * 
 * % Daily Value not established.

OTHER INGREDIENTS:

Gelatin, Glycerine, Purified Water, Sodium Alginate, Stearic Acid. This product contains purified fish oil.

DESCRIPTION:

OBSTETRIX™ DHA is a multivitamin/multi-mineral dietary supplement with Omega-3 Fatty Acids indicated for 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 softgel daily; before, during and after pregnancy, with or without food, or as directed by a physician.

PRECAUTIONS:

PRECAUTIONS SECTION

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. Administration of OBSTETRIX™ DHA Omega-3 Fatty Acids should be avoided in patients taking anticoagulants.

Sold only in combination pack with OBSTETRIX™ DHA prenatal caplets.

STORAGE:

SAFE HANDLING WARNING SECTION

Optimum storage condition= 30 to 40% Relative Humidity & 59 to 86° F (15-30°C). Protect from extreme temperatures. Freezing & excessive heat may damage softgels.

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 to help prevent burp back

Obstetrix™ DHA Caplets

STATEMENT OF IDENTITY SECTION

 Supplement Facts
 Serving Size: 1 Caplet / Servings Per Container: 30
Amount% Daily
Per Serving Value**
 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™ DHA is 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™ DHA 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.

Sold only in combination pack with OBSTETRIX™ DHA softgels.

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

with 100% Bioactive Folate

• Enteric coated
• Well tolerated
• Easy to swallow

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

One caplet and one softgel daily or as directed by a physician.

HOW SUPPLIED:

SAFE HANDLING WARNING SECTION

OBSTETRIX™ DHA is available as a combination pack, which contains: Bottle of 30 DHA translucent soft gels and a Bottle of 30 orange, oval shaped tablets with imprinted “OBX". Available in Box of 30 x 2 Count Bottles 11026-2629-3 and as professional samples in Box of 7 x 2 Count Bottles. The listed product number is not a National Drug Code, but rather a product code assigned, formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.

Store at room temperature, approximately 15°-30°C (59° to 86°F), avoid excessive heat, light and moisture.

Manufactured in the USA for:
SEYER PHARMATEC 
Caguas, Puerto Rico 00725

HEALTH CLAIM SECTION

Dietary Supplement

The Preferred Prenatal

The small, well-tolerated, prenatal duo, formulated to ensure compliance.†

Enteric coated to help prevent burp back, well tolerated, and easy to swallow.†

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Seyer-2629-1Seyer-2629-1Seyer-2629-2Seyer-2629-2Seyer-2629-3Seyer-2629-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1549965docosahexaenoic acid 350 MG Oral CapsulePSN1
1549965docosahexaenoic acid 350 MG Oral CapsuleSCD1

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
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
cd2aa2bf-3a9a-4fb3-9436-a62d0a299fa7Product name120230823
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11026-2629-3Obstetrix DHA Combo Pack1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11026-2629OBSTETRIX DHA COMBO PACK (DOCOSAHEXAENOIC ACID, 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) KIT [SEYER PHARMATEC, INC.]11 package rows20230228_00c008e9-f314-4d35-bb2a-6140f970d429.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11026-2629-3EA - Each11026-26295cf99ded-86ee-4b0d-90e8-6316996a13df12023-03-13

Products#

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

DailyMed product names page 1 of 2 · 65 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11026-262911026-2629-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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