FOLIC ACID 1 mg/5mL
folic acid · SOLUTION · Ayurax, LLC
Folic acid oral solution is a B vitamin supplement used to treat or prevent folic acid deficiency, which can occur due to poor nutrition, certain medical conditions, or medications. This liquid form contains 1 mg of folic acid per 5 mL and is taken by mouth as prescribed by your doctor.
Key Facts
- Brand Name
- FOLIC ACID
- Generic Name
- folic acid
- NDC Code (Product)
73308-501- Manufacturer
- Ayurax, LLC
- Strength
- 1 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA216395
- Marketing Start
- 01/28/2026
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD70655_14, EXP: 5/28/2014; MELATONIN, Tablet, 3 mg, NDC
Tri-Coast Pharmacy
Lack of Assurance of Sterility
Tri-Coast Pharmacy
Lack of Assurance of Sterility
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Lack of Assurance of Sterility
Promise Pharmacy, LLC
Lack of sterility assurance.
TMC Acquisition LLC dba Tailor Made Compounding
Lack of Assurance of Sterility
Downing Labs, LLC
Lack of Assurance of Sterility
Promise Pharmacy, LLC
Lack of sterility assurance.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Virtus Pharmaceuticals, Llc
Defective Delivery System: Product may contain leaking capsules.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
Dosage & Administration
DOSAGE AND ADMINISTRATION Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb folic acid given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral or enteral alimentation). Doses greater than 0.1 mg should not be used unless anemia due to vitamin B 12 deficiency has been ruled out or is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess is excreted unchanged in the urine. The usual therapeutic dosage in adults and children (regard less of age) is up to 1 mg daily. Resistant cases may require larger doses. When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. I…
Warnings
WARNING Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.
Contraindications
CONTRAINDICATIONS Folic acid is contraindicated in patients who have shown previous intolerance to the drug.
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 diphe…
Frequently Asked Questions
What is FOLIC ACID used for?
Folic acid oral solution is a B vitamin supplement used to treat or prevent folic acid deficiency, which can occur due to poor nutrition, certain medical conditions, or medications. This liquid form contains 1 mg of folic acid per 5 mL and is taken by mouth as prescribed by your doctor.
Is FOLIC ACID a controlled substance?
FOLIC ACID is not classified as a controlled substance by the DEA.
What is the generic name for FOLIC ACID?
The generic name for FOLIC ACID is folic acid. There are 11 other brand versions of folic acid.
What is the NDC code for FOLIC ACID 1 mg/5mL?
The NDC (National Drug Code) for FOLIC ACID 1 mg/5mL is 73308-501, listed by Ayurax, LLC.