Label: OBSTETRIX 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

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 10, 2023

If you are a consumer or patient please visit this version.

  • Obstetrix™ DHA Softgels

     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:

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

  • PRECAUTIONS:

    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:

    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

    Dietary Supplement

    • Enteric coated to help prevent burp back

  • Obstetrix™ DHA Caplets

     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:

    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

    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:

    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:

    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

    Dietary Supplement

    with 100% Bioactive Folate

    • Enteric coated
    • Well tolerated
    • Easy to swallow

  • OBSTETRIX™ DHA Combo Pack

  • DOSAGE AND ADMINISTRATION:

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

  • HOW SUPPLIED:

    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

    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

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

  • INGREDIENTS AND APPEARANCE
    OBSTETRIX 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
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:11026-2629
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:11026-2629-31 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 30 
    Part 21 BOTTLE 30 
    Part 1 of 2
    OBSTETRIX DHA SOFTGEL 
    docosahexaenoic acid capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT350 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FISH OIL (UNII: XGF7L72M0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement02/22/2023
    Part 2 of 2
    OBSTETRIX DHA CAPLET 
    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
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE810 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-8.1 mg
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE40 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM1700 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON29 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE30 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SELENIUM65 ug
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    SUCROSE (UNII: C151H8M554)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POVIDONE K60 (UNII: SZR7Z3Q2YH)  
    SOYBEAN COTYLEDON CELL WALL POLYSACCHARIDES (UNII: 4UL6DF56YQ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBIC ACID (UNII: X045WJ989B)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement02/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement02/22/2023
    Labeler - Seyer Pharmatec, Inc. (832947126)