Mediclarum
Medicine guide

Folic Acid

1 mg · Tablet

  • Prescription only
Active substance
Folic Acid
Made by
Amneal Pharmaceuticals of New York LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-04-15

Used for
  • 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…
The label’s usual adult dose

Adults and children (regard less of age) is up to 1 mg daily.

Full directions ↓
Do not take it if

Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
37other products contain Folic Acid — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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.

From the official label · 2026-04-15 · DailyMed

How it works

From this product’s own US prescribing label.

Folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow.

In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis.

Peak level after1 h
How the body breaks it down

Folic acid is metabolized in the liver to 7,8-dihydrofolic acid and eventually to 5,6,7,8-tetrahydrofolic acid with the aid of reduced diphosphopyridine nucleotide (DPNH) and folate reductases.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-04-15

Do not take it if

Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.
  • General Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.
  • There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.
  • This may result in severe nervous system damage before the correct diagnosis is made.
  • Adequate doses of vitamin B 12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.
  • Drug Interactions There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid.
  • A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.
  • Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.
  • False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of Lactobacillus casei.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic potential and studies to evaluate the mutagenic potential or effect on fertility have not been conducted.
  • Pregnancy Teratogenic Effects Pregnancy Category A Folic acid is usually indicated in the treatment of megaloblastic anemias of pregnancy.
  • Folic acid requirements are markedly increased during pregnancy, and deficiency will result in fetal damage (see INDICATIONS AND USAGE ).
  • Studies in pregnant women have not shown that folic acid increases the risk of fetal abnormalities if administered during pregnancy.
  • If the drug is used during pregnancy, the possibility of fetal harm appears remote.
  • Because studies cannot rule out the possibility of harm, however, folic acid should be used during pregnancy only if clearly needed.
  • Nursing Mothers Folic acid is excreted in the milk of lactating mothers.
  • During lactation, folic acid requirements are markedly increased; however, amounts present in human milk are adequate to fulfill infant requirements, although supplementation may be needed in low- birth-weight infants, in those who are breast-fed by mothers with folic acid deficiency (50 mcg daily), or in those with infections or prolonged diarrhea.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious anemia has been ruled out.
  • Patients with pernicious anemia receiving more than 0.4 mg of folic acid daily who are inadequately treated with vitamin B 12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B 12 deficiency will progress.
  • Doses of folic acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately.

Quoted from the official label, section “Overdosage”.

Side effects

  • 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.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • Folic Acid Tablets USP, 1 mg, are supplied as light yellow colored, round convex tablet debossed "AN 361" on one side and bisected on the other side.
  • They are available as follows:
  • Bottles of 100:
  • NDC 53746-361-01 Bottles of 1,000:
  • NDC 53746-361-10 Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Protect from light and moisture.
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by:
  • Amneal Pharmaceuticals Pvt.
  • Ltd.
  • Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by:
  • Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2026-01

Quoted from the official label, section “How Supplied”.

What is in it

  • Folic acid, N-[ p -[[(2-amino-4- hydroxy-6-pteridinyl) methyl]- amino] benzoyl]-Lglutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para -aminobenzoic acid, which is joined by a peptide linkage to glutamic acid.
  • Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables.
  • Commercially available folic acid is prepared synthetically.
  • Folic acid, USP occurs as a yellow or yellowish-orange, odorless, crystalline powder.
  • It is very slightly soluble in water and insoluble in alcohol.
  • Folic acid, USP is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate).
  • Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light.
  • The structural formula of folic acid is as follows: C 19 H 19 N 7 O 6 M.W.
  • 441.40 Each tablet, for oral administration, contains 1 mg folic acid, USP.
  • Folic acid tablets, USP 1 mg contain the following inactive ingredients:
  • lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, Type A and stearic acid. 1

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (27)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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CanadaNo exact match for this strength and form

Every strength and form (4)

Details

Made byAmneal Pharmaceuticals of New York LLC
Active substanceFolic Acid
Strength1 mg
FormTablet
RouteOral
Packs100 TABLET in 1 BOTTLE · 1000 TABLET in 1 BOTTLE
NDC53746-361

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

30 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Folic Acid1 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Folic AcidFolic Acid1 mgPrescription onlyTablet Major Pharmaceuticals · Folic AcidFolic Acid1 mgPrescription onlyTablet SUNRISE PHARMACEUTICAL, INC. · Folic AcidFolic Acid1 mgPrescription onlyTablet Rising Pharma Holdings, Inc. · Folic AcidFolic Acid5 mg/mLPrescription onlyInjection, Solution XGen Pharmaceuticals DJB, Inc. · Folic AcidFolic Acid1 mgPrescription onlyTablet PD-Rx Pharmaceuticals, Inc. · Folic Acid

See every product with Folic Acid