Label: SELECT OB- .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium, and zinc tablet, chewable
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated September 22, 2014
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Each caplet contains: Vitamin A 1,700 IU Vitamin C 60 mg Vitamin D 400 IU Vitamin E 30 IU Thiamine Mononitrate (Vitamin B1) 1.6 mg Riboflavin (Vitamin B2) 1.8 mg Niacin (as niacinamide) 15 mg Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folic Acid 1 mg Vitamin B12 (as Cyanocobalamin) 5 mcg Elemental Iron (as polysaccharide iron complex) 29 mg Magnesium (as magnesium oxide) 25 mg Zinc (as zinc oxide) 15 mg
Other Ingredients: Fructose, Stearic Acid, Mono and Diglycerides, Croscarmellose Sodium, Mixed Berry Flavor WONF, Gelatin (Porcine), Silicon Dioxide, Citric Acid, Magnesium Stearate, Modified Food Starch, Hydroxypropylmethyl Cellulose, Malic Acid, Sucrose, Corn Starch, Dicalcium Phosphate, Sodium Ascorbate, Medium Chain Triglycerides, Sorbic Acid, Tocopherol Concentrate, Sodium Benzoate, dl-Alpha-Tocopherol, Butylated Hydroxytoluene (BHT), Tricalcium Phosphate. Coating: Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polydextrose, Hydroxypropyl Cellulose, Triacetin, Polyethylene Glycol, FD&C Blue #1/Aluminum Lake, FD&C Blue #2/Aluminum Lake. Contains Soy.
- INDICATIONS AND USAGE
SELECT-OB® is contraindicated in patients with hypersensitivity to any of its components or color additives.
Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.
Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).
- BOXED WARNING (What is this?)
SELECT-OB® should be used with caution in patients with known sensitivity or allergy to soy.
Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Prolonged use of iron salts may produce iron storage disease.
Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.
Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid overdosage. Keep out of the reach of children.
High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.
Zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. Consult appropriate references for additional specific vitamin-drug interactions.
Information for Patients
Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
INGREDIENTS AND APPEARANCE
.beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium, and zinc tablet, chewable
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0642-0077 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .Beta.-Carotene (UNII: 01YAE03M7J) (.Beta.-Carotene - UNII:01YAE03M7J) .Beta.-Carotene 600 [iU] VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1100 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.6 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.8 mg Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 15 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 2.5 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.4 mg LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM 0.6 mg Cobalamin (UNII: 8406EY2OQA) (Cobalamin - UNII:8406EY2OQA) Cobalamin 5 ug Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 29 mg Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium 25 mg Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 15 mg Inactive Ingredients Ingredient Name Strength FRUCTOSE (UNII: 6YSS42VSEV) STEARIC ACID (UNII: 4ELV7Z65AP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MALTODEXTRIN (UNII: 7CVR7L4A2D) HYPROMELLOSES (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYDEXTROSE (UNII: VH2XOU12IE) MAGNESIUM STEARATE (UNII: 70097M6I30) MALIC ACID (UNII: 817L1N4CKP) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) TRIACETIN (UNII: XHX3C3X673) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) ACACIA (UNII: 5C5403N26O) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) SODIUM ASCORBATE (UNII: S033EH8359) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) Product Characteristics Color BLUE Score no score Shape OVAL Size 19mm Flavor BERRY Imprint Code EV0077 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0642-0077-90 90 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/04/2005 Labeler - Everett Laboratories, Inc. (071170534)