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Substance · official US FDA label

Acide Folique (folic acid)

67 medicines listed on Vimpia contain it, alone or combined. Below, the official US FDA label for folic acid, unchanged.

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This is a US label.

The official US FDA label for folic acid, effective September 11, 2026, describes products sold in the United States. The medicine sold in DR Congo may differ in strength, form or approved uses: ask a pharmacist or a doctor.

Official US FDA label for folic acid

Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. The full label on DailyMed.

Uses

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

US dosage, for products sold in the United States. For a medicine bought in DR Congo, follow its box, its leaflet or your pharmacist.

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 B12 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 (regardless 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. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

Warnings and precautions

WARNING Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Side effects

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 B12 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.

Medicines that contain it

Names as they are sold. A medicine without an English page links to its French page.

Sources

  • ●Labels: U.S. Food and Drug Administration, openFDA (public domain). Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. DailyMed.
  • ●English names of substances: RxNorm, U.S. National Library of Medicine.
  • ●Marketing authorizations: register of the ACOREP, DR Congo.
  • ●Essential medicines: national list of essential medicines of DR Congo (LNME).
  • ●Composition: public medicines database of France (BDPM), ANSM, open licence.

Public information, for reference only: it does not replace the advice of a pharmacist or a doctor. Vimpia writes nothing about how to use a medicine and translates nothing: the label is the US FDA's, unchanged; names, composition and authorizations come from the official sources above.