Each round coated beige colored tablet contains:

Active Ingredients:

Folacin	(Folic Acid)	2.5 mg
Pyridoxine	(B6)	25 mg
Cyanocobalamin	(B12)	2 mg

Inactive Ingredients:

Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose, Opadry II Beige 40L174427 (Titanium Dioxide, Polydextrose, Hypromellose 3cP, Hypromellose 6cP, Triacetin, Hypromellose 50cP, Polyethylene Glycol 8000, FD&C Yellow # 6-Lake, FD&C Blue # 2-Lake, FD&C Red #40-Lake), Crospovidone, Croscarmellose Sodium, Magnesium Stearate (Vegetable Source), Opadry II Clear #Y-19-7483 (Hypromellose 6cP, Maltodextrin, Hypromellose 3cP, PEG 400, Hypromellose 50cP).

FOLTX® tablets do not contain sugar, or lactose.

Last updated on RxList: 6/30/2008

FOLTX tablets are indicated for the distinct nutritional requirements of individuals under a physician's treatment for hyperhomocysteinemia; with particular emphasis for individuals with or at risk for atherosclerotic vascular disease in the coronary¹, peripheral², or cerebral³ vessels, or vitamin B₁₂ deficiency⁴.

Usual adult dose is one to two tablets daily or as directed by a physician.

Available as a round coated beige colored tablet. Debossed with "PAL" on one side and (heart outline) on the other. Supplied in bottles of 90 tablets.

Storage

Store at controlled room temperature between 15° -30°C (59° -86°F) (See USP). Protect from light and moisture. Dispense in original light-resistant container with child resistant closure.

NDC# 00525-0906-90

References

^1,2 Eilelboom JW, Lonna Eva, Genest Jr Jaques, Hankey Graeme, Yusuf Salim: Homocysteine and Cardiovascular Disease: A Critical Review of the Epidemiologic Evidence. Ann Intern Med. 1999; 131:363-375.

³ The Homocysteine Studies Collaboration: Homocysteine and Risk of Ischemic Heart Disease and Stroke. JAMA 2002; Vol 288, No. 16:2015-2002.

⁴ Refsum Helga, Smith A. David, Ueland Per M, Nexo Ebba, Clarke Robert, McPartlin Joseph, Johnston Carole, Engbaek Frode, Scheede Jorn, McPartlin Catherime, and Scott John M.: Facts and Recommendations about Total Homocysteine Determinations: An Expert Opinion. Clinical Chemistry 2004; 50:1 3-32.

Manufactured For PAMLAB, L.L.C. Covington, LA. Revised 03/07. FDA Rev date: n/a

Last updated on RxList: 6/30/2008

Allergic sensitization has been reported following both oral and parenteral administration of folacin (folic acid). Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body has been associated with cyanocobalamin.

Pyridoxine supplements should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

Last updated on RxList: 6/30/2008

No information provided.

Folacin (folic acid) when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 2 mgs of cyanocobalamin contained in FOLTX has been shown to provide an adequate amount of cyanocobalamin to address this precaution⁵. Unmetabolized folic acid has been shown in one study of 105 postmenopausal women (50-75yrs) to have the potential to reduce natural killer cells' cytotoxicity, which may result in an impaired immune response⁶.

Cyanocobalamin should not be used in those with Leber's optic atrophy. Decreased levels of B₁₂ have been associated with reduced ability to detoxify the cyanide in exposed individuals and cyanocobalamin may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder.

Hydroxocobalamin can aid in the detoxification of cyanide. This form of B₁₂ is an acceptable form for B₁₂ supplementation in those with this disorder.

Pregnant women and nursing mothers should only use 12 microgram doses of B₁₂ (cyanocobalamin) from nutritional supplements. Doses higher than this should only be recommended by your physician.

Administration of doses of vitamin B₁₂ greater than 10 micrograms daily may produce a hematological response in those with anemia secondary to folate deficiency.

References

⁵ Kuzminski AM, Del Giacco EJ, Allen RH, et al: Effective Treatment of Cobalamin Deficiency with Oral Cobalamin. Blood 1998; 92:1191-1198.

⁶ Troen AM, Mitchell B, Sorensen B, Wener MH, Johnston A, Wood B, Selhub J, McTierman A, Yasui Y, Oral E, Potter JD, and Ulich CM: Unmetabolized Folic Acid in Plasma is Associated with Reduced Natural Killer Cell Cytoxicity among Postmenopausal Women. Journal of Nutrition 2006 Jan; 136(1): 189-194.

Last updated on RxList: 6/30/2008

No information provided.

Known hypersensitivity to any of the components in the product is a contraindication.

Last updated on RxList: 6/30/2008

No information provided.

Last updated on RxList: 6/30/2008

FOLTX tablets are a medical food, for use only under the direction and supervision of a licensed physician.

Last updated on RxList: 6/30/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

VITAMIN B-12/FOLIC ACID/VITAMIN B-6 - ORAL

(vitamin B12/FOH-lick/vitamin B6)

COMMON BRAND NAME(S): Folgard, Folgard RX 2.2, Foltx, Homocysteine Formula

USES: This combination of vitamins provides vitamin B-6, vitamin B-12 and folic acid to people who do not have enough of these vitamins for good health.

HOW TO USE: Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If stomach upset occurs, it may help to take this product with food.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. The dosage is based on your medical condition and response to therapy.

SIDE EFFECTS: Nausea, stomach upset, diarrhea, drowsiness, flushing, and numbness/tingling may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, unusual weakness.

A very serious allergic reaction to this product is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: certain blood disorders (e.g., pernicious anemia, other anemias).

This drug may make you drowsy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This product should not be used with the following medications because very serious interactions may occur: altretamine, cisplatin, levodopa (when used without carbidopa).

If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication.

Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: folic acid antagonist (e.g., methotrexate), hydantoins (e.g., phenytoin, diphenylhydantoin), pyrimethamine, other vitamin/nutritional supplements.

This product can affect the results of certain lab tests (e.g., intrinsic factor antibodies, certain urobilinogen tests). Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, homocysteine levels) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

Remember that it is best to get your vitamins and minerals from healthy foods. Maintain a well-balanced diet and follow any dietary guidelines as directed by your doctor. B vitamins, including folic acid, are naturally found in leafy greens, other vegetables, and citrus fruits. Folic acid is also found in enriched grains such as bread, pasta and cereal.

Some brands of this medication may also contain ingredients such as vitamin E, para-aminobenzoic acid, or alpha-lipoic acid. Consult your doctor or pharmacist if you have questions about the ingredients in your brand.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.