Label: PRENATAL- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, and zinc oxide tablet, coated

  • NHRIC Code(s): 76413-325-01
  • Packager: Central Texas Community Health Centers
  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated September 29, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SAFE HANDLING WARNING

    TAMPER EVIDENT: Do not use if imprinted safety seal under cap is broken or missing
  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving% DV*
    *
    % Daily Value for Pregnant and Lactating Women
    Vitamin A (Palmitate)4000 IU50%
    Vitamin C (Ascorbic Acid)120 mg200%
    Vitamin D (Cholecalciferol)400 IU100%
    Vitamin E (dl - Alpha Tocopheryl Acetate)30 IU100%
    Vitamin B-1 (Thiamine Mononitrate)1.8 mg106%
    Vitamin B-2 (Riboflavin)1.7 mg85%
    Niacin (Niacinamide)20 mg100%
    Vitamin B-6 (Pyridoxine HCl)2.6 mg104%
    Folic Acid0.8 mg100%
    Vitamin B-12 (Cyanocobalamin)8 mcg100%
    Calcium (Calcium Carbonate)200 mg15%
    Iron (Ferrous Fumarate)28 mg156%
    Zinc (Oxide)25 mg167%

    Other ingredients: cellulose, croscarmellose sodium, magnesium stearate, hypromellose, PEG, mineral oil, titanium dioxide, talc, FD&C Red #40, FD&C Yellow #6, FD&C Blue #2

  • INDICATIONS

    For use as a dietary supplement prior to conception, during pregnancy and during the postnatal period, for both the nursing and non-nursing mother.

  • DIRECTIONS

    For adults, one tablet daily, preferably with food. Ask your health care provider before taking any supplements or medications.

  • WARNINGS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six.
    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN
    In case of accidental overdose, call a doctor or Poison Control Center immediately.
  • HEALTH CLAIM

    Store at room temperature (59° - 86°F).

    REV 0615

    DIST. BY: GERI-CARE
    PHARMACEUTICALS CORP.
    1650 63rd Street
    Brooklyn, NY 11204

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    CommUnityCare Federally Qualified Health Centers

    PRENATAL
    VITAMINS
    # 100

    Date:

    Name:
    Dr.

    TAKE 1 TABLET DAILY AS DIRECTED BY PHYSICIAN.

    1/1/11

    123456

    PRENATAL VITAMINS #100TABS NDC 76413-325-01

    Batch:
    123456
    Lot:
    123456
    Exp:
    1/1/11

    GERICARE

    Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

    Principal Display Panel - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    PRENATAL 
    vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, and zinc oxide tablet, coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:76413-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T) Vitamin A4000 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid120 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol Acetate30 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.8 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.7 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine2.6 mg
    Folic acid (UNII: 935E97BOY8) (Folic acid - UNII:935E97BOY8) Folic acid0.8 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin8 ug
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) Calcium Carbonate200 mg
    Ferrous fumarate (UNII: R5L488RY0Q) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation28 mg
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide25 mg
    Inactive Ingredients
    Ingredient NameStrength
    powdered cellulose (UNII: SMD1X3XO9M)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    magnesium stearate (UNII: 70097M6I30)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    mineral oil (UNII: T5L8T28FGP)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    talc (UNII: 7SEV7J4R1U)  
    FD&C Red NO. 40 (UNII: WZB9127XOA)  
    FD&C Yellow NO. 6 (UNII: H77VEI93A8)  
    FD&C Blue NO. 2 (UNII: L06K8R7DQK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:76413-325-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT06/01/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)20 mm
    Labeler - Central Texas Community Health Centers (079674019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Texas Community Health Centers079674019REPACK, RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceuticals611196254MANUFACTURE, REPACK
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!