NDC | 68025-010-10 |
Set ID | 1c91079b-546e-400a-a342-b2223cd26a01 |
Category | DIETARY SUPPLEMENT |
Packager | Vertical Pharmaceuticals, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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SUPPLEMENT FACTS
Other Ingredients: Microcrystalline Cellulose, Di Cal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc and FDC Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Povidone K30, Acacia
GLUTEN-, LACTOSE- AND SUGAR-FREE
OB Complete® is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and non-lactating mothers.
Other Ingredients: Microcrystalline Cellulose, Di Cal Phosphate, Croscarmellose Sodium, Pink Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Red #40 Lake), Fumed Silica, Stearic Acid, Magnesium Stearate, Povidone K30, Acacia.
GLUTEN, SUGAR AND LACTOSE FREE
- CONTRAINDICATIONS
- WARNINGS
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PRECAUTIONS
Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
- DRUG INTERACTIONS
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ADVERSE REACTIONS
Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
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WARNINGS
KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.
For use on the order of a healthcare practitioner
Call your doctor about side effects. To report side effects, call Vertical Pharmaceuticals at 1-877-95-VERTI (1-877-958-3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Customer Service: 1-866-600-4799 Rev. 08/2018
Distributed by:
Vertical Pharmaceuticals, LLC
Bridgewater, NJ 08807
www.verticalpharma.com
- PRINCIPAL DISPLAY PANEL - 100 Caplet Blister Pack Carton
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INGREDIENTS AND APPEARANCE
OB COMPLETE PRENATAL
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, pantothenic acid, iron pentacarbonyl, magnesium oxide, zinc oxide, and copper gluconate tabletProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:68025-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .beta.-carotene (UNII: 01YAE03M7J) (.beta.-carotene - UNII:01YAE03M7J) .beta.-carotene 2100 [iU] ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) ascorbic acid 120 mg cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol 315 [iU] .alpha.-tocopherol succinate, D- (UNII: LU4B53JYVE) (.alpha.-tocopherol, D- - UNII:N9PR3490H9) .alpha.-tocopherol, D- 20 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 2 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 3.4 mg NIACINAMIDE (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) NIACINAMIDE 10 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 10 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1.25 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 15 ug Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid 5 mg IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 50 mg Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Cation 15 mg Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation 10 mg COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline (UNII: OP1R32D61U) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) Croscarmellose Sodium (UNII: M28OL1HH48) hypromelloses (UNII: 3NXW29V3WO) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) titanium dioxide (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Talc (UNII: 7SEV7J4R1U) FD&C Red No. 40 (UNII: WZB9127XOA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) Magnesium Stearate (UNII: 70097M6I30) povidone K30 (UNII: U725QWY32X) acacia (UNII: 5C5403N26O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68025-010-10 10 in 1 CARTON 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 12/31/2010 02/29/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color imprint scoring 1 shape size (solid drugs) 19 mm Labeler - Vertical Pharmaceuticals, LLC (173169017)