Label: OBSTETRIX 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
- NHRIC Code(s): 11026-2630-3
- Packager: Seyer Pharmatec, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 12, 2023
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STATEMENT OF IDENTITY
Supplement Facts Amount % Daily Serving Size: 1 Softgel / Servings Per Container: 30 Per Serving 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 calcium L-5-methyltetrahydrofolate) (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, titanium dioxide, FD&C Red #40, FD&C Blue #1), soy lecithin, white beeswax.
Manufactured in the USA for:
Seyer Pharmatec, Inc
Caguas, Puerto Rico 00725To report a serious adverse event or to obtain product information, contact (888) 444-5072.
DESCRIPTION: Obstetrix™ One is a prenatal vitamin and mineral supplementation 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 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.†
†This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. -
WARNINGS
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 with individuals that have a known hypersensitivity to any of the ingredients. This product is not for use in children under 12 years of age.
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CAUTION:
This product contains 1 mg 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 progress.
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™ One should be avoided in patients taking anticoagulants.
ADDITIONAL INFORMATION: Product contains FASTER Act of 2021 allergen: Soy. Product contains bio-engineered (BE) ingredient.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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- OTHER INFORMATION:
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INGREDIENTS AND APPEARANCE
OBSTETRIX 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 coatedProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:11026-2630 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 18 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 6.25 ug .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 10 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 30 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 1.7 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 15 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 38 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 15 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 225 mg Inactive Ingredients Ingredient Name Strength GELATIN TYPE B BOVINE (230 BLOOM) (UNII: WIL1404U79) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:11026-2630-3 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/13/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 14 mm scoring 1 Labeler - Seyer Pharmatec, Inc. (832947126)
