Virt-Vite Forte

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, multivitamins are not expected to cause serious side effects. Less serious side effects may include:

• upset stomach;
• headache; or
• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of a multivitamin. Avoid taking more than one multivitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your multivitamin with a full glass of water.

The chewable tablet must be chewed before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use multivitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep the liquid medicine from freezing.

Store multivitamins in their original container. Storing multivitamins in a glass container can ruin the medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Certain minerals may also cause serious overdose symptoms if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• If you have an allergy to folic acid, cyanocobalamin, pyridoxine, or any other part of Virt-Vite Forte (folic acid, cyanocobalamin, and pyridoxine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have an eye problem called Leber's optic atrophy.
• If you are taking levodopa.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Virt-Vite Forte with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

1. Wu A, Chanarin I, Levi AJ. Macrocytosis of chronic alcoholism. The Lancet. 1974;1:829-31.
2. Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981; 16:263-67.
3. De-Regil LM, Fernández-Gaxiola AC, Dowswell T, et al. Effects and safety of periconceptional folate supplementation for preventing birth defects. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD007950. doi: 10.1002/14651858.CD007950.pub2.
4. Federal Register Notice of April 9, 1971 (36 FR 6843).
5. The Federal Register Notice of August 2, 1973 (38 FR 20750).
6. The Federal Register Notice of October 17, 1980 (45 FR 69044).
7. The Federal Register Notice of August 2, 1973 (38 FR 20750).
8. Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
9. The Federal Register Notice of March 5, 1996 (61 FR 8760).
10. Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000.
11. Code of Federal Regulations Title 21 Section 172.345.
12. Code of Federal Regulations Title 21 Section 101.9(j)(8).
13. Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7.

PREGNANCY and NURSING MOTHERS: Virt-Vite Forte Tablets is not intended for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. This product contains B vitamins in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

DOSAGE AND ADMINISTRATION: One to two tablets daily or as directed by a licensed medical practitioner.

HOW SUPPLIED: Virt-Vite Forte Tablets are round coated pink tablets debossed on one side with “V201”, and are supplied in bottles of 90 tablets.

STORAGE: Store at Controlled Room Temperature 15°-30° C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.