Indications and uses
Niva-Plus™ is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
Niva-Plus™ Tablets
- Manufacturer
- Nivagen Pharmaceuticals, Inc.
- Effective date
- 2015-03-12
- Label type
- DIETARY SUPPLEMENT
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:48:03
Label at a glance#
ProductNiva-Plus
Active ingredientFOLIC ACID, VITAMIN A, ASCORBIC ACID, CALCIUM SULFATE, FERROUS FUMARATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, CUPRIC OXIDE
Label structure15 sections
Dosage and administration
Before, during and after pregnancy, one tablet daily, or as prescribed by a physician.
Label contents#
Full prescribing information#
HEALTH CLAIM SECTION
Rx Only
DESCRIPTION
Niva-Plus™ is an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. Niva-Plus™ is an oval, beige tablet with "N050" debossed on one side.
HEALTH CLAIM SECTION
| Supplement Facts Servings per Bottle: 100 | ||
|---|---|---|
| Serving Size: 1 tablet Each tablet contains: | % DV Adults & Children 4 Years or More | |
| Folic Acid | 1 mg | 250% |
| Vitamin A (Input as vitamin A acetate and beta carotene) | 4000 IU | 80% |
| Vitamin C (ascorbic acid) | 120 mg | 200% |
| Calcium (calcium sulfate) | 200 mg | 20% |
| Iron (ferrous fumarate) | 27 mg | 150% |
| Vitamin D3 (cholecalciferol) | 400 IU | 100% |
| Vitamin E (dl-alpha-tocopheryl acetate) | 22 IU | 157% |
| Vitamin B1 (thiamine mononitrate) | 1.84 mg | 123% |
| Vitamin B2 (riboflavin) | 3 mg | 176% |
| Niacinamide (vitamin B3) | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl) | 10 mg | 500% |
| Vitamin B12 (cyanocobalamin) | 12 mcg | 200% |
| Zinc (zinc oxide) | 25 mg | 167% |
| Copper (cupric oxide) | 2 mg | 100% |
Other Ingredients: Microcrystalline Cellulose, Beige Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Yellow #6 Lake, FD&C Blue #2 Lake), Pregelatinized Starch, Croscarmellose Sodium, Di Calcium Phosphate, Magnesium Stearate, Stearic Acid, Fumed Silica, Ascorbyl Palmitate.
INDICATIONS AND USAGE
Niva-Plus™ is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
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 REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. |
PRECAUTIONS
General
Folic acid, when prescribed as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
PATIENT INFORMATION
Niva-Plus™ is a prescription vitamin for the use only under the direction and supervision of a licensed physician.
INTERACTIONS
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Drugs which may interact with folate include:
- Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the levels of this AED in the blood and allowing breakthrough seizures to occur.
- Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
- Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
- Colestipol: Reduces folic acid absorption and reduces serum folate levels.
- Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
- Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
- Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
- Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
- Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
- Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
- Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.
- Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
- Smoking and alcohol: Reduced serum folate levels have been noted.
- Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
- Metformin treatment in patients with type 2 diabetes decreases serum folate.
- Warfarin can produce significant impairment in folate status after a 6 - month therapy.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates - including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.
Ferrous Fumarate
Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although, the absorption of iron is best when taken between meals, occasional gastrointestinal disturbances may be controlled giving Niva-Plus™ shortly after meals.
DOSAGE AND ADMINISTRATION
Before, during and after pregnancy, one tablet daily, or as prescribed by a physician.
HOW SUPPLIED
Niva-Plus™ is supplied as:
Bottles of 100 tablets: 75834-050-01
SAFE HANDLING WARNING SECTION
KEEP OUT OF REACH OF CHILDREN
HEALTH CLAIM SECTION
Rx Only
Manufactured for:
Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827
nivagen.com
Rev. 09/14
PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
75834-050-01
Rx Only
Niva-Plus™
Tablets
NIVAGEN
PHARMACEUTICALS
100 TABLETS
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 |
| CHOLECALCIFEROL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
| VITAMIN A Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75834-050-01 | Niva-Plus | 100 in 1 BOTTLE | TABLET, COATED | 100 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 75834-050 | NIVA-PLUS (FOLIC ACID, VITAMIN A, ASCORBIC ACID, CALCIUM SULFATE, FERROUS FUMARATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, AND CUPRIC OXIDE) TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.] | 1 | 1 package rows | 20150319_58754e85-0104-44ec-bb0a-acc64677e329.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75834-050-01 | EA - Each | 75834-050 | 86988d4c-51f7-4eed-b020-45b070cfee91 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | ACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| CALCIUM SULFATE | ACTIVE INGREDIENT | WAT0DDB505 | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CUPRIC OXIDE | ACTIVE INGREDIENT | V1XJQ704R4 | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| FERROUS FUMARATE | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| NIACINAMIDE | ACTIVE INGREDIENT | 25X51I8RD4 | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| VITAMIN A | ACTIVE INGREDIENT | 81G40H8B0T | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL, DL- | ACTIVE MOIETY | 7QWA1RIO01 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| FERROUS CATION | ACTIVE MOIETY | GW89581OWR | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| NIACINAMIDE | ACTIVE MOIETY | 25X51I8RD4 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE ION | ACTIVE MOIETY | 4ABT0J945J | 1 | |
| VITAMIN A | ACTIVE MOIETY | 81G40H8B0T | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Niva-Plus
- FOLIC ACID, VITAMIN A, ASCORBIC ACID, CALCIUM SULFATE, FERROUS FUMARATE, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, and CUPRIC OXIDE
- FOLIC ACID
- VITAMIN A
- ASCORBIC ACID
- CALCIUM SULFATE
- CALCIUM CATION
- FERROUS FUMARATE
- FERROUS CATION
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL ACETATE, DL-
- .ALPHA.-TOCOPHEROL, DL-
- THIAMINE MONONITRATE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- CYANOCOBALAMIN
- ZINC OXIDE
- CUPRIC OXIDE
- CUPRIC CATION
- CELLULOSE, MICROCRYSTALLINE
- HYPROMELLOSES
- POLYVINYL ALCOHOL
- TITANIUM DIOXIDE
- POLYETHYLENE GLYCOLS
- TALC
- FD&C YELLOW NO. 6
- ALUMINUM OXIDE
- FD&C BLUE NO. 2
- CROSCARMELLOSE SODIUM
- CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
- MAGNESIUM STEARATE
- STEARIC ACID
- SILICON DIOXIDE
- ASCORBYL PALMITATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75834-050 | 75834-050-01 |
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 |
|---|---|---|---|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE / ORAL | 322 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SOLUTION / TOPICAL | 1.4 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | SYSTEM / TOPICAL | 420 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET / ORAL | 165 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED PELLETS / ORAL | 14 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | GEL / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET / ORAL | 2240 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| POLYVINYL ALCOHOL | POLYVINYL ALCOHOL | 532B59J990 | TABLET, COATED / ORAL | 0.7 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| ALUMINUM OXIDE | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE / ORAL | 72 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, CHEWABLE / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | TABLET, CHEWABLE / ORAL | 50 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | SOAP / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Folic Acid | FOLIC ACID | REMEDYREPACK INC. | bda4687e-929a-434d-ab59-909cf2ed73a2 | 2026-09-11 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | REMEDYREPACK INC. | 368b69a8-a021-47e3-a6d7-e3497d7363b1 | 2026-09-04 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Rising Pharma Holdings, Inc. | 0baa10dd-6d1d-4946-8236-566451132da3 | 2026-07-24 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Northwind Health Company, LLC | 03b0aee4-804a-de63-e063-6394a90a6635 | 2026-07-13 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Unit Dose Solutions, Inc. | 54db8b21-87b9-5e0c-e063-6394a90ae8ea | 2026-06-22 | Warnings, Adverse reactions | FOLIC ACID |
| Vitramyn | FOLIC ACID | PureTek Corporation | c8af7616-5178-6df0-e053-2a95a90a334d | 2026-06-18 | Warnings, Adverse reactions | FOLIC ACID |
| FOLIC ACID | FOLIC ACID | Coupler LLC | 544e394d-3555-8ab1-e063-6394a90ade00 | 2026-06-15 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Major Pharmaceuticals | 7778ac96-7817-455a-a177-22ecb276c67f | 2026-05-26 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | QUAGEN PHARMACEUTICALS LLC | 354366ea-3702-4706-9fc0-0244b7278bd8 | 2026-05-20 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Cardinal Health 107, LLC | 624469a1-ded9-453a-973e-c5a2f0602bb0 | 2026-05-15 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Cardinal Health 107, LLC | 6dd867fe-597e-4915-8baf-98a605bf9324 | 2026-05-06 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | a1b71c5d-c842-43fd-9557-2bb4e934b914 | 2026-04-23 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Preferred Pharmaceuticals Inc. | b4c3a754-64cd-499a-a32f-a6e935c41355 | 2026-04-22 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Amneal Pharmaceuticals of New York LLC | fd85395e-6a0b-4072-a80b-36095c0c6dd6 | 2026-04-15 | Warnings, Adverse reactions | FOLIC ACID |
| Multitam | FOLIC ACID | PureTek Corporation | cee15842-4a9e-c6ba-e053-2a95a90aebc5 | 2026-04-13 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | XGen Pharmaceuticals DJB, Inc. | c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9 | 2026-01-21 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Aphena Pharma Solutions - Tennessee, LLC | 40ab3c91-5a5b-fa1d-e063-6394a90a7454 | 2025-12-10 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | American Health Packaging | fc6dc1e1-f63e-4239-a1eb-67525569f68c | 2025-11-13 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | 4889d474-bd72-46ba-81d6-5511d8a85abb | 2025-11-04 | Warnings, Adverse reactions | FOLIC ACID |
| Folic Acid | FOLIC ACID | Bryant Ranch Prepack | 41914ac8-f4f5-4d70-b9f2-9f88c59d67a6 | 2025-10-29 | Warnings, Adverse reactions | FOLIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.