Label: PRENATAL PLUS- vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated

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

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Drug Label Information

Updated January 17, 2020

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  • DESCRIPTION

    Prenatal Plus Vitamin and Mineral Tablet is an Tan-Yellow colored, modified oval biconvex film coated tablet debossed G12 on one side, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

    Each Prenatal Plus tablet Contains:

    Vitamin A (Acetate and Beta Carotene) .......................................4000 I.U.

    Vitamin C (Ascorbic acid)……………………………………...........….120 mg

    Vitamin D-3 (Cholecalciferol)……………….....................................400 I.U.

    Vitamin E (dl- Alpha Tocopheryl Acetate)……………………...............22 mg

    Thiamine (Vitamin B-1 from Thiamine Mononitrate………............…1.84 mg

    Riboflavin (Vitamin B-2)………………………………………...............…3 mg

    Niacin(Niacinamide)……………………………………………………....  20 mg

    Vitamin B-6 (Pyridoxine HCl)…………………………………................10 mg

    Folic Acid……………………………………………………............……...1 mg

    Vitamin B-12 (Cyanocobalamin)……………………………................12 mcg

    Calcium (Calcium Carbonate)……………………………….........…....200 mg

    Iron (Ferrous Fumarate)………………………………………...........…...27 mg

    Zinc (Zinc Oxide)………………………………………………...........…..25 mg

    Copper (Cupric Oxide)…………………………………………...........… ..2 mg

    Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow #5, FD&C Yellow #6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc,
    titanium dioxide

  • Indication

    To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception

  • Dosage

    As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

  • BOXED WARNING (What is this?)

    Warning: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • Precautions

    Folic Acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

  • STORAGE AND HANDLING

    STORE AT CONTROLLED ROOM TEMPERATURE 15 0 - 30 0C (59 0 - 86 0F). AVOID EXCESS HEAT.

  • HOW SUPPLIED

    Dispense in a well closed light-resistant container, with a child resistant container.

  • PRINCIPAL DISPLAY PANEL

    Vitamin and Mineral
    Tablet

    Multi-Vitamin

    Rx Only                      100 Tablets



    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

    DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

    Questions or comments call 1-855-361-3993

    Manufactured For:
    AvKARE, Inc.
    Pulaski, TN 38478


    Mfg.Rev. 09/12      AV Rev. 07/17 (P)

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    NDC 42291-686-01

    Prenatal Plus

    Vitamin and Mineral
    Tablet

    Multi-Vitamin

    100 Tablets        Rx Only                     



    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

    DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

    Manufactured For: AvKARE, Inc.
    Pulaski, TN 38478

    Prenatal Plus Vitamin and Mineral Tablet (100 Tablets)

    Mfg. Rev. 09/12
    AV Rev. 07/17 (P)

  • INGREDIENTS AND APPEARANCE
    PRENATAL PLUS 
    vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric oxide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42291-686(NDC:65162-668)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A3080 [iU]
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-22 mg
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE920 [iU]
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Coloryellow (Tan-Yellow) Scoreno score
    ShapeOVAL (Modified Oval Biconvex) Size19mm
    FlavorImprint Code G12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42291-686-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/11/2012
    Labeler - AvKARE, Inc. (796560394)