NDC | 68025-059-30 |
Set ID | 6bffb66f-6b1b-44e2-ba4d-211091e99ef7 |
Category | DIETARY SUPPLEMENT |
Packager | Vertical Pharmaceuticals, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
-
SUPPLEMENT FACTS
Other Ingredients: Soybean Oil, Yellow Bees Wax, Lecithin, Gelatin, Purified Water, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Blue #1.
CONTAINS: SOY AND FISH OIL (ANCHOVY)
GLUTEN-, LACTOSE-, AND SUGAR-FREE
OB Complete® Petite 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.
- CONTRAINDICATIONS
- WARNINGS
-
PRECAUTIONS
Folic acid alone is 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
OB Complete®Petite softgel capsules are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).
-
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
-
HEALTH CLAIM
KEEP OUT OF REACH OF CHILDREN.
PATENTED FORMULA. U.S. PAT. No. 8,263,137
**Sumalate® (Ferrous Asparto Glycinate) is a registered trademark of Albion International, Inc. and is covered by the following patents:
U.S. Pat. No. 6,716,814, U.S. Pat. No. 8,007,846 and U.S. Pat. No. 8,425,956.
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. 06/2018
Distributed by:
Vertical Pharmaceuticals, LLC
Bridgewater, NJ 08807
- PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
-
INGREDIENTS AND APPEARANCE
OB COMPLETE PETITE
calcium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron, ferrous asparto glycinate, zinc oxide, cupric sulfate, and doconexent capsule, liquid filledProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:68025-059 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 75 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 1000 [iU] .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 30 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J) THIAMINE 2 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 30 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 15 ug IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 35 mg FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 5 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 200 mg Inactive Ingredients Ingredient Name Strength SOYBEAN OIL (UNII: 241ATL177A) YELLOW WAX (UNII: 2ZA36H0S2V) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) ETHYL VANILLIN (UNII: YC9ST449YJ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:68025-059-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 10/26/2012 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color imprint scoring 1 shape size (solid drugs) 15 mm Labeler - Vertical Pharmaceuticals, LLC (173169017)