Label: PROTECT IRON- vitamin c, vitamin e, thiamin, riboflavin, niacin, vitamin b6, folate, vitamin b12, biotin, pantothenic acid, calcium, iron, magnesium, zinc, selenium, copper, manganese, molybdenum, coenzyme q10, citrus bioflavonoids, l cystine, ascorbyl palmitate, bioperine tablet

  • NHRIC Code(s): 58552-316-30, 58552-316-02
  • Packager: GIL PHARMACEUTICAL CORP.
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 5, 2022

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Tablet

    Amount Per Serving                                                

    % DailyValue

    Vitamin C                                                   

    (as Calcium Ascorbate and Magnesium Ascorbate)

    500 mg

    556%

    Vitamin E (as d-Alpha Tocopheryl Succinate)

    67 mg

    447%

    Thiamin (as Thiamine HCl)

    15 mg

    1250%

    Riboflavin                                                    

    15 mg

    1154%

    Niacin (Vitamin B-3)

    20 mg

     125%

    Vitamin B-6 (as Pyridoxine HCl)

    15 mg

     882%

    Folate

    1700 mcg DFE

    (1000 mcg Folic Acid)

     425%

    Vitamin B-12 (as Cyanocobalamin)

    100 mcg

    4167%

    Biotin                                          

    50 mcg

    167%

    Pantothenic Acid (as Calcium Pantothenate)

    15 mg

    300%

    Calcium (as Calcium Malate,

          Dicalcium Phosphate and Calcium Ascorbate)

    80 mg

        6%

    Iron (as Polysaccharide Iron)

    60 mg

        333%

    Magnesium (as Magnesium Ascorbate and

                            Magnesium Amino Acid Chelate)

    32 mg

    8%

    Zinc (as Zinc Amino Acid Chelate)

    5 mg

    45%

    Selenium (as Selenium Amino Acid Chelate)

    10 mcg

    18%

    Copper (as Copper Amino Acid Chelate)

    1 mg

    111%

    Manganese (as Manganese Amino Acid Chelate)

    2 mg

    87%

    Molybdenum (as Molybdenum Amino Acid Chelate)

    10 mcg

    22%

    Coenzyme Q-10

    30 mg

    *

    Citrus Bioflavonoids

    25 mg

    *

    L-Cystine

    25 mg

    *

    Ascorbyl Palmitate

    10 mg

    *

    Bioperine™

    5 mg

    *

    *Daily Value (DV) not established.

  • WARNINGS

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

  • STATEMENT OF IDENTITY

    KEEP OUT OF THE REACH OF CHILDREN.

    Store at room temperature, USP.

  • SAFE HANDLING WARNING

    †These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

  • HEALTH CLAIM

    Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Hypromellose, Citric Acid, Dicalcium Phosphate, Magnesium Stearate, Silica, Glycine, Triacetin, Rice Flour, FD&C Yellow #6 Lake, Titanium Dioxide, Mineral Oil, FD&C Red #40 Lake, Ethyl Vanillin, FD&C Blue #1 Lake and Talc.

    **Bioperine™ is a trademark of Sabinsa.
    Contains: Soy.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

    Take one tablet daily or one tablet twice a day (one in the morning and one in the evening) or as directed by your physician. For children under 12 years of age, consult your physician.

  • PRECAUTIONS

    MANUFACTURED FOR:
    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

    DO NOT ACCEPT IF SEAL IS MISSING OR BROKEN.
    PROFESSIONAL SAMPLE, NOT FOR SALE

  • PAKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Protect Iron Metabolic Optimization NDC-58552-316-30 - 30s Label

    image description

    Protect Iron Metabolic Optimization -NDC-58552-316-02-2s Label

    image description

  • INGREDIENTS AND APPEARANCE
    PROTECT IRON 
    vitamin c, vitamin e, thiamin, riboflavin, niacin, vitamin b6, folate, vitamin b12, biotin, pantothenic acid, calcium, iron, magnesium, zinc, selenium, copper, manganese, molybdenum, coenzyme q10, citrus bioflavonoids, l cystine, ascorbyl palmitate, bioperine tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:58552-316
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID500 mg
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL67 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE15 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN15 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE15 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.7 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.1 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.05 mg
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID15 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM80 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON60 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM32 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC5 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM0.01 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER1 mg
    MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P) MANGANESE2 mg
    MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM0.01 mg
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE30 mg
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O) CITRUS BIOFLAVONOIDS25 mg
    CYSTINE (UNII: 48TCX9A1VT) (CYSTINE - UNII:48TCX9A1VT) CYSTINE25 mg
    ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE10 mg
    PIPERINE (UNII: U71XL721QK) (PIPERINE - UNII:U71XL721QK) PIPERINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCINE (UNII: TE7660XO1C)  
    TRIACETIN (UNII: XHX3C3X673)  
    BROWN RICE (UNII: 659G217HPG)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:58552-316-3030 in 1 PACKAGE
    2NHRIC:58552-316-022 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement11/05/2022
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    shape
    size (solid drugs)2 mm
    scoring1
    color
    Labeler - GIL PHARMACEUTICAL CORP. (176826592)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.057795122analysis, label, manufacture, pack
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