FDA.reportPublic FDA data

PROTECT IRON

Manufacturer
GIL PHARMACEUTICAL CORP. | Contract Pharmacal Corp.
Effective date
2022-11-05
Label type
DIETARY SUPPLEMENT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:36

Label at a glance#

ProductPROTECT IRON
Active ingredientASCORBIC ACID, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACIN, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, PANTOTHENIC ACID, CALCIUM, IRON, MAGNESIUM, ZINC, SELENIUM, COPPER, MANGANESE, MOLYBDENUM, UBIDECARENONE, CITRUS BIOFLAVONOIDS, CYSTINE, ASCORBYL PALMITATE, PIPERINE
Label structure8 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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 SECTION

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 SECTION

KEEP OUT OF THE REACH OF CHILDREN.

Store at room temperature, USP.

SAFE HANDLING WARNING SECTION

†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 SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

image descriptionimage description

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

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
COPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NIACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-316-02PROTECT IRON2 in 1 PACKAGETABLET21
58552-316-30PROTECT IRON30 in 1 PACKAGETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-316PROTECT 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 [GIL PHARMACEUTICAL CORP.]12 package rows20221125_5c1c07a3-8483-486f-8bcd-c15c171b315d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-316-30EA - Each58552-316c01a7131-9c48-441c-a70d-6d6044dec1a112022-12-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58552-31658552-316-30, 58552-316-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1ACTIB
THIAMINEX66NSO3N35ACTIB
RIBOFLAVINTLM2976OFRACTIB
NIACIN2679MF687AACTIB
PYRIDOXINEKV2JZ1BI6ZACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
BIOTIN6SO6U10H04ACTIB
PANTOTHENIC ACID19F5HK2737ACTIB
CALCIUMSY7Q814VUPACTIB
IRONE1UOL152H7ACTIB
MAGNESIUMI38ZP9992AACTIB
ZINCJ41CSQ7QDSACTIB
SELENIUMH6241UJ22BACTIB
COPPER789U1901C5ACTIB
MANGANESE42Z2K6ZL8PACTIB
MOLYBDENUM81AH48963UACTIB
UBIDECARENONEEJ27X76M46ACTIB
CITRUS BIOFLAVONOIDSBD70459I50ACTIB
CYSTINE48TCX9A1VTACTIB
ASCORBYL PALMITATEQN83US2B0NACTIB
PIPERINEU71XL721QKACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCINETE7660XO1CIACT
TRIACETINXHX3C3X673IACT
BROWN RICE659G217HPGIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MINERAL OILT5L8T28FGPIACT
FD&C RED NO. 40WZB9127XOAIACT
ETHYL VANILLINYC9ST449YJIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ascorbic AcidASCORBIC ACIDRenova Pharmaceuticals LLCa6481bae-2397-44c7-a51d-4f47ad91bd2c2026-08-19Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
AscorASCORBIC ACIDMcGuff Pharmaceuticals, Inc.388aad52-fc01-4784-9791-1dbc80c693062026-05-29Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
generic name: ASCORBIC ACID
Skin Renewing SerumASCORBIC ACIDGuangzhou Danting Bath&Body Care Industry Co. Ltd396c2a8d-ac95-cbef-e063-6294a90aff392025-08-23WarningsName fallback
generic name: ASCORBIC ACID

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.