Label: OBSTETRIX 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
- NHRIC Code(s): 11026-2632-6
- Packager: Seyer Pharmatec, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 14, 2023
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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Caplet / Servings Per Container: 60 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™ 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:
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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.
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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
- Packaging
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INGREDIENTS AND APPEARANCE
OBSTETRIX 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 tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:11026-2632 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 NHRIC:11026-2632-6 60 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/14/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 13 mm scoring 1 imprint Labeler - Seyer Pharmatec, Inc. (832947126)
