Label: SELECT OB- .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, and zinc oxide tablet, chewable

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 21, 2014

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  • DESCRIPTION

    Supplement Facts
    Serving Size 1 Caplet
    Each Caplet contains% Daily Value
    Vitamin A (as beta carotene and acetate)1700 IU21%
    Vitamin C (as ascorbic acid)60 mg100%
    Vitamin D (as cholecalciferol)400 IU100%
    Vitamin E (as dl-alpha tocopheryl acetate)30 IU100%
    Thiamin (Vitamin B1)1.6 mg94%
    Riboflavin (Vitamin B2)1.8 mg90%
    Niacin (as niacinamide)15 mg75%
    Vitamin B6 (as pyridoxine hydrochloride)2.5 mg100%
    Folate (as Folic acid USP 0.4 mg and
      L-methylfolate calcium 0.6 mg)
    mg125%
    Vitamin B12 (as cobalamin)mcg63%
    Iron (as polysaccharide iron complex)29 mg161%
    Magnesium (as magnesium oxide)25 mg6%
    Zinc (as zinc oxide)15 mg100%

    Other Ingredients: Fructose, stearic acid, mono and diglycerides of edible fatty acids, croscarmellose sodium, natural berry flavor, modified food starch, maltodextrin, hydroxypropylmethylcellulose, silicon dioxide, citric acid, titanium dioxide (as color), polydextrose, magnesium stearate, malic acid, hydroxypropylcellulose, triacetin, corn starch, sucrose, acacia, polyethylene glycol, dibasic calcium phosphate, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, dl-alpha-tocopheryl.

  • CONTRAINDICATIONS

    SELECT-OB® Chewable Caplets are 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?)

    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 a Poison Control Center immediately.

  • WARNINGS/PRECAUTIONS

    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.

    Avoid overdosage. Keep out of the reach of children.

    Drug Interactions

    High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid. Folic acid may decrease a patient's response to methotrexate. 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

    Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in SELECT-OB® Chewable Caplets. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

  • HOW SUPPLIED

    SELECT-OB® Chewable Caplets are available as a light blue, caplet debossed "EV0120". Available in bottle of 90 and as professional samples.

    Rx

  • USAGE

    SELECT-OB® Chewable Caplets provide vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

  • DIRECTIONS FOR USE

    Before, during and after pregnancy, chew or swallow one blue SELECT-OB® Chewable Caplet daily, or as directed by a physician.

    You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349.

  • SPL UNCLASSIFIED SECTION

    KEEP OUT OF REACH OF CHILDREN.

  • STORAGE AND HANDLING

    Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat, light and moisture.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    EVERETT LABORATORIES, INC.
    Chatham, NJ 07928
    1-877-324-9349

  • PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label

    0642-0120-90

    Select-OB®

    Chewable Caplets
    Prenatal Supplement

    90 Caplets

    Rx

    PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
  • INGREDIENTS AND APPEARANCE
    SELECT OB 
    .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, and zinc oxide tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE600 [iU]
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1100 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [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) THIAMINE1.6 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.8 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID0.4 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM0.6 mg
    COBALAMIN (UNII: 8406EY2OQA) (COBALAMIN - UNII:8406EY2OQA) COBALAMIN5 ug
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON29 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLUEScoreno score
    ShapeOVALSize19mm
    FlavorBERRYImprint Code EV0120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0120-9090 in 1 BOTTLE
    2NDC:0642-0120-033 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER07/14/2014
    Labeler - Everett Laboratories, Inc. (071170534)