Dosage and administration
Adults and children over 12 years of age: One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.
Iron Folate Plus
- Manufacturer
- Westminster Pharmaceuticals, LLC
- Effective date
- 2023-07-19
- Label type
- DIETARY SUPPLEMENT
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:50:51
Label at a glance#
ProductIron Folate Plus
Active ingredientFERROUS FUMARATE, IRON, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE
Label structure15 sections
Contacts and useful links#
Label contents#
Full prescribing information#
STATEMENT OF IDENTITY SECTION
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Capsule Servings Per Container: 90 | ||
| Amount Per Serving | % DV for Adults and Children over 12 | |
| Vitamin C (Ascorbic Acid)* | 210 mg | 233% |
| Thiamin (as Thiamine Mononitrate) | 5 mg | 417% |
| Riboflavin | 5 mg | 385% |
| Niacin | 20 mg | NE 125% |
| Vitamin B6 (as Pyridoxine HCI) | 25 mg | 1471% |
| Folate | 1667 mcg DFE (1000 mcg folic acid) | 417% |
| Vitamin B12 (as Cyanocobalamin) | 10 mcg | 417% |
| Biotin | 300 mcg | 1000% |
| Pantothenic Acid (as D-Calcium Pantothenate) | 7 mg | 140% |
| Iron (from Ferrous Fumarate and Polysaccharide Iron Complex) | 125 mg | 694% |
* Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including, calcium ascorbate, magnesium ascorbate, potassium ascorbate, and sodium ascorbate; (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin complex; and (4) Glutathione.
Other Ingredients: Hydroxypropyl Methyl Cellulose, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Yellow #5
HEALTH CLAIM SECTION
Iron Folate Plus is a prescription multivitamin nutritional supplement indicated for improving nutritional status in adults with certainty illnesses or vitamin deficiencies. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.
CONTRAINDICATIONS
Iron Folate Plus is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
WARNINGS
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. |
PRECAUTIONS
General
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.
Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.
Pediatric Use
Safety and effectiveness of this product have not been established in pediatric patients.
Geriatric Use
Safety and effectiveness of this product have not been established in elderly patients.
DRUG INTERACTIONS
Iron Folate Plus is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g. Aspirin, Heparin, Clopidogrel).
ADVERSE REACTIONS
Folic Acid
Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
Ferrous Fumarate
Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, taking Iron Folate Plus after meals may diminish occasional G.I. disturbances. Iron Folate Plus is best absorbed when taken at bedtime.
OVERDOSAGE
Acute overdosage of iron may cause abdominal pain, nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other more chronic symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. Toxic effects are seen at 10-20 mg/kg elemental iron. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Iron Folate Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this product out of the reach of children.
Treatment
For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.
DESCRIPTION
Iron Folate Plus are yellow capsules imprinted "218" in black.
DIRECTIONS FOR USE
Adults and children over 12 years of age: One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.
HOW SUPPLIED
Iron Folate Plus is dispensed in child-resistant bottles of 90 Capsules (69367-218-09) and 30 Capsules (69367-218-30).
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
HEALTH CLAIM SECTION
KEEP OUT OF REACH OF CHILDREN.
For use on the order of a healthcare practitioner.
HEALTH CLAIM SECTION
To report a serious adverse event contact 1-844-221-7294
Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Rev. 06/23
PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
69367-218-09
Rx
Iron Folate
Plus
with Ascorbic Acid Precursors
IRON / FOLIC ACID / VITAMIN
DIETARY SUPPLEMENT
90 Capsules
Westminster
Pharmaceuticals
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NIACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| cf050ccd-1144-f76a-e00d-e5698d8597d4 | Product name | 6 | 20250625 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| 910c1bd7-67d1-44c7-ad4f-9445f827edcc | Product name | 1 | 20230808 |
| 91c62db0-0295-c81c-d10a-0856c259edd6 | Product name | 2 | 20200428 |
| d32bc2b8-0bb7-2216-87aa-24639646e202 | Product name | 3 | 20190619 |
| e2dae634-14ed-febf-08ee-93196433b5b7 | Product name | 9 | 20190614 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
| 0a5e5249-329b-0cff-e714-77159f193a87 | Product name | 1 | 20140508 |
| 6b7a6f32-42a6-994d-5ab6-d180e92ee9d8 | Product name | 1 | 20140508 |
| d394f843-7479-dc48-dbd3-232266c5548c | Product name | 1 | 20140508 |
| dc9a5fb6-14e2-1cc8-a567-a781fd1f0212 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69367-218-09 | Iron Folate Plus | 90 in 1 BOTTLE | CAPSULE | 90 | 3 | |
| 69367-218-30 | Iron Folate Plus | 30 in 1 BOTTLE | CAPSULE | 30 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69367-218-09 | EA - Each | 69367-218 | ae1a27ed-f06e-45e0-8f7f-67ad357455c7 | 1 | 2023-10-16 |
| 69367-218-30 | EA - Each | 69367-218 | 439e5e6e-168a-4bbe-99e9-f41df02d7e30 | 1 | 2023-10-16 |
Products#
Every source-derived product name is available through these pages.
- Iron Folate Plus
- FERROUS FUMARATE
- FERROUS CATION
- IRON
- ASCORBIC ACID
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACIN
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- BIOTIN
- CALCIUM PANTOTHENATE
- PANTOTHENIC ACID
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- SILICON DIOXIDE
- MAGNESIUM STEARATE
- TITANIUM DIOXIDE
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69367-218 | 69367-218-30, 69367-218-09 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FERROUS FUMARATE | R5L488RY0Q | ACTIM |
| IRON | E1UOL152H7 | ACTIB |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| THIAMINE MONONITRATE | 8K0I04919X | ACTIR |
| RIBOFLAVIN | TLM2976OFR | ACTIB |
| NIACIN | 2679MF687A | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIM |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| BIOTIN | 6SO6U10H04 | ACTIB |
| CALCIUM PANTOTHENATE | 568ET80C3D | ACTIM |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C YELLOW NO. 5 | I753WB2F1M | IACT |
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.