Dosage and administration
One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.
Folivane™-OB Capsules
- Manufacturer
- Trigen Laboratories, LLC
- Effective date
- 2022-01-07
- Label type
- DIETARY SUPPLEMENT
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 02:50:19
Label at a glance#
ProductFolivane-OB
Active ingredientFerrous Fumarate, Iron, Ascorbic Acid, Folic Acid, Thiamine Mononitrate, Riboflavin, Niacin, Calcium Pantothenate, Pyridoxine Hydrochloride, Biotin, Cyanocobalamin, Cupric Sulfate, MAGNESIUM SULFATE HEPTAHYDRATE, Manganese Sulfate, Zinc Sulfate
Label structure13 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SUPPLEMENT FACTS
Other Ingredients: Capsule (Hypromellose, Titanium Dioxide, FD&C Blue #1, FD&C Red #40) Microcrystalline Cellulose, Magnesium Stearate, and Fumed Silica.
Folivane™-OB is a prescription prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Folivane™-OB may also be used to improve the nutritional status of women. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.
CONTRAINDICATIONS
Folivane™-OB 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 anemia. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
WARNING
| 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. |
PRECAUTION
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 cardiovascular diagnostic tests (e.g. troponin) and hormone test, and may 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
Folivane™-OB 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 sensitization 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, giving Folivane™-OB after meals may control occasional G.I. disturbances. Folivane™-OB 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. Folivane™-OB should be stored beyond the reach of children to prevent against accidental iron poisoning.
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
Folivane™-OB are blue opaque capsules imprinted with “T535” in white ink on both cap and body.
DIRECTIONS FOR USE
One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.
HOW SUPPLIED
Folivane™-OB is dispensed in child-resistant bottles of 30 capsules.
Product Code: 13811-535-30
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
KEEP OUT OF REACH OF CHILDREN.
HEALTH CLAIM SECTION
For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-770-509-4500 or FDA at 1-800-FDA-1088.
PLR-FOLOB-00001-1 Rev. 12/2021
Manufactured for:
Trigen Laboratories, LLC
Alpharetta, GA 30005
1-770-509-4500
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
13811-535-30
Folivane™-OB
with Ascorbic Acid Precursors
PRENATAL MULTIVITAMIN SUPPLEMENT
30 CAPSULES
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASCORBIC ACID Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CALCIUM CATION Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20230427 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| MAGNESIUM CATION Pharmacologic Class Indexing | 4 | Indexing - Pharmacologic Class | 20180813 |
| MANGANESE CATION (2+) 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 |
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13811-535-30 | Folivane-OB | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13811-535 | FOLIVANE-OB (FERROUS FUMARATE, IRON, ASCORBIC ACID, FOLIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, CALCIUM PANTOTHENATE, PYRIDOXINE HYDROCHLORIDE, BIOTIN, CYANOCOBALAMIN, CUPRIC SULFATE, MAGNESIUM SULFATE, MANGANESE SULFATE, AND ZINC SULFATE) CAPSULE [TRIGEN LABORATORIES, LLC] | 6 | 1 package rows | 20220108_b22f46ab-96dd-4e85-9b15-deb372daa82a.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-535-30 | EA - Each | 13811-535 | 37a7e7c5-2d97-4504-a8ab-77012ac53de5 | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ascorbic Acid | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| Biotin | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| Calcium Pantothenate | ACTIVE INGREDIENT | 568ET80C3D | 1 | |
| Cupric Sulfate | ACTIVE INGREDIENT | LRX7AJ16DT | 1 | |
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| Ferrous Fumarate | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| Folic Acid | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| Iron | ACTIVE INGREDIENT | E1UOL152H7 | 1 | |
| Magnesium Sulfate | ACTIVE INGREDIENT | DE08037SAB | 1 | |
| Manganese Sulfate | ACTIVE INGREDIENT | W00LYS4T26 | 1 | |
| Niacin | ACTIVE INGREDIENT | 2679MF687A | 1 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| Riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| Thiamine Mononitrate | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| Zinc Sulfate | ACTIVE INGREDIENT | 89DS0H96TB | 1 | |
| Ascorbic Acid | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| Biotin | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| Calcium Cation | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| Cupric Cation | ACTIVE MOIETY | 8CBV67279L | 1 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| Ferrous Cation | ACTIVE MOIETY | GW89581OWR | 1 | |
| Folic Acid | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| Iron | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| Magnesium Cation | ACTIVE MOIETY | T6V3LHY838 | 1 | |
| Manganese Cation (2+) | ACTIVE MOIETY | H6EP7W5457 | 1 | |
| Niacin | ACTIVE MOIETY | 2679MF687A | 1 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| Riboflavin | ACTIVE MOIETY | TLM2976OFR | 1 | |
| Thiamine Ion | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| Zinc Cation | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Folivane-OB
- Ferrous Fumarate, Iron, Ascorbic Acid, Folic Acid, Thiamine Mononitrate, Riboflavin, Niacin, Calcium Pantothenate, Pyridoxine Hydrochloride, Biotin, Cyanocobalamin, Cupric Sulfate, Magnesium Sulfate, Manganese Sulfate, and Zinc Sulfate
- Ferrous Fumarate
- Ferrous Cation
- Iron
- Ascorbic Acid
- Folic Acid
- Thiamine Mononitrate
- Thiamine Ion
- Thiamine
- Riboflavin
- Niacin
- Calcium Pantothenate
- Calcium Cation
- Pyridoxine Hydrochloride
- Pyridoxine
- Biotin
- Cyanocobalamin
- Cupric Sulfate
- Cupric Cation
- MAGNESIUM SULFATE HEPTAHYDRATE
- Magnesium Cation
- Manganese Sulfate
- MANGANOUS CATION
- Zinc Sulfate
- Zinc Cation
- Hypromelloses
- Cellulose, Microcrystalline
- Magnesium Stearate
- Titanium Dioxide
- FD&C Blue No. 1
- FD&C Red No. 40
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13811-535 | 13811-535-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, FILM COATED / ORAL | 0.16 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | GEL / RECTAL | 348 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | SYRUP / ORAL | 250 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| Hypromelloses | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.