1 INDICATIONS AND USAGE FOLIC ACID oral solution is indicated for the treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients.

FOLIC ACID oral solution is a folate analog indicated for the treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients.

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6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risk of Obscuring Diagnosis of Pernicious Anemia [see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of folic acid were identified in clinical studies or post marketing reports.

Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse Reactions: Hypersensitivity reactions including rash, itching, malaise, and bronchospasm.

Gastrointestinal reactions (nausea, anorexia, abdominal distension, flatulence, dysgeusia) Neurological reactions (altered sleep patterns, difficulty concentrating, irritability, overactivity, excitement, depression, confusion, impaired judgement) Decreased vitamin B 12 serum levels (with prolonged folic acid therapy).

Increased seizures in patients with epilepsy receiving phenobarbital, primidone, or diphenylhydantoin The most common adverse reactions are nausea, anorexia, and bloating.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ayurax, LLC at 1-844-551-9911 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.