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
- NHRIC Code(s): 11026-2629-3
- Packager: Seyer Pharmatec, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 10, 2023
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Obstetrix™ DHA Softgels
Supplement Facts Serving Size: 1 Softgel / Servings Per Container: 30 Amount % Daily Per Serving Value 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:
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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.
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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 00725DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
- HEALTH CLAIM
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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% Riboflavin 3.4 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:
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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.
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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.
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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 00725DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
- HEALTH CLAIM
- OBSTETRIX™ DHA Combo Pack
- DOSAGE AND ADMINISTRATION:
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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
- Packaging
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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 kitProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:11026-2629 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:11026-2629-3 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 30 Part 2 1 BOTTLE 30 Part 1 of 2 OBSTETRIX DHA SOFTGEL
docosahexaenoic acid capsule, liquid filledProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 350 mg Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM ALGINATE (UNII: C269C4G2ZQ) STEARIC ACID (UNII: 4ELV7Z65AP) FISH OIL (UNII: XGF7L72M0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/22/2023 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 tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE 810 ug ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 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 HYDROCHLORIDE 3 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 40 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 1700 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 29 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 30 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70) SELENIUM 65 ug Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/22/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/22/2023 Labeler - Seyer Pharmatec, Inc. (832947126)