warnings
WARNINGS Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.
FOLIC ACID
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- FOLIC ACID
- Generic name
- FOLIC ACID
- Manufacturer
- Unit Dose Solutions, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 54db8b21-87b9-5e0c-e063-6394a90ae8ea
- SPL ID
- 54db8d28-2bb4-3ae4-e063-6294a90aa5ad
- Version
- 1
- Effective date
- 2026-06-22
- Source export date
- 2026-08-01
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:01:55
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 040796 | derived:openfda.application_number |
| application number | ANDA040796 | openfda.application_number | |
| brand name | FOLIC ACID | openfda.brand_name | |
| generic name | FOLIC ACID | openfda.generic_name | |
| manufacturer name | Unit Dose Solutions, Inc. | openfda.manufacturer_name | |
| ndc | package | 87441-032-01 | openfda.package_ndc |
| ndc | product | 87441-032 | openfda.product_ndc |
| ndc11 | package | 87441003201 | derived:openfda.package_ndc |
| rxcui | 310410 | openfda.rxcui | |
| spl id | 54db8d28-2bb4-3ae4-e063-6294a90aa5ad | id | |
| spl set id | 54db8b21-87b9-5e0c-e063-6394a90ae8ea | set_id | |
| unii | 935E97BOY8 | openfda.unii |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B 12 serum levels may occur in patients receiving prolonged folic acid therapy. In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of folic acid daily. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500.