Label: M-NATAL PLUS- vitamin a, vitamin c, vitamin d, vitamin e, thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, calcium, iron, zinc, copper tablet

  • 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.

Drug Label Information

Updated October 6, 2020

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  • SPL UNCLASSIFIED SECTION

    M-Natal Plus tablet

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving% Daily Value for Pregnant and Lactating Women
    Vitamin A (as Acetate and Beta Carotene)4000 IU50%
    Vitamin C (Ascorbic Acid)120 mg200%
    Vitamin D (Vitamin D3 as cholecalciferol)400 IU100%
    Vitamin E (dl-Alpha Tocopheryl Acetate)22 IU73%
    Thiamine (Vitamin B1 from Thiamine Mononitrate)1.84 mg108%
    Riboflavin (Vitamin B2)3 mg150%
    Niacin (Niacinamide)20 mg100%
    Vitamin B6 (as Pyridoxine HCl)10 mg400%
    Folic Acid1 mg125%
    Vitamin B12 (Cyanocobalamin)12 mcg150%
    Calcium200 mg15%
    Iron (Ferrous Fumarate)27 mg150%
    Zinc (Zinc Oxide)25 mg167%
    Copper (Cupric Oxide)2 mg100%

    Other Ingredients: Microcrystalline Cellulose, Croscarmellose Sodium, Polyvinyl Alcohol, Stearic Acid, Titanium Dioxide, Polyethylene Glycol, Talc, Magnesium Stearate, Silicon Dioxide, Beet Powder, Caramel, Carnauba Wax.

  • DESCRIPTION

    M-Natal Plus Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.

  • DOSAGE AND ADMINISTRATION

    Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.

  • WARNING:

    Accidental overdose of iron-containing products is aleading cause of fatal poisoning in children under 6. Keep thisproduct out of reach of children. In case of accidental overdose,call a doctor or poison control center immediately.

  • CAUTION

    High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

    Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

    Call your licensed medical practitioner about side effects. You mayreport side effects by calling Method at 1-877-250-3427 or FDA at1-800-FDA-1088.

  • HOW SUPPLIED

    NDC: 63629-1140-1 100 tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    M-Natal Plus Oral Tablet 27-1 MG

    Label
  • INGREDIENTS AND APPEARANCE
    M-NATAL PLUS 
    vitamin a, vitamin c, vitamin d, vitamin e, thiamine, riboflavin, niacin, vitamin b6, folic acid, vitamin b12, calcium, iron, zinc, copper tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-1140(NDC:58657-170)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A4000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE22 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARAMEL (UNII: T9D99G2B1R)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    Colorbrown (baige) Scoreno score
    ShapeRECTANGLE (oblong) Size19mm
    FlavorImprint Code M170
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-1140-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-1140) , RELABEL(63629-1140)