VIVA CT PRENATAL- folic acid, ferrous fumarate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, zinc oxide, cupric sulfate anhydrous, and selenomethionine tablet, chewable
JayMac Pharmaceuticals LLC
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30ct round, light pink to pink-colored, fruit-flavored chewable tablets, embossed VCT
Prescription PRENATAL/POSTNATAL Vitamin
Viva® CT Prenatal Chewable is an orally administered, chewable prescription PRENATAL/POSTNATAL vitamin specifically formulated for the dietary management of individuals with unique nutritional needs requiring increased folate levels. Viva® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.
Each ROUND, LIGHT TO PINK-colored, chewable tablet contains the following dietary ingredients:
|Folic Acid||1 mg*|
|Iron (ferrous fumarate)||28 mg*|
|Vitamin C (ascorbic acid)||100 mg*|
|Vitamin D3 (cholecalciferol)||400 IU*|
|Vitamin E (acetate)||30 IU*|
|Vitamin B1 (thiamine mononitrate)||3 mg*|
|Vitamin B2 (riboflavin)||3 mg*|
|Vitamin B6 (pyridoxine HCl)||50 mg*|
|Vitamin B12 (cyanocobalamin)||15 mcg*|
|Zinc (oxide)||20 mg*|
|Copper (sulfate)||1 mg*|
The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, I-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate. Folic acid, including the reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.
The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that: Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b) (3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).
Viva® CT Prenatal Chewable is indicated for the distinct nutritional requirements of individuals in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. This product can be used fordietary management prior to conception. Viva® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.
Viva® CT Prenatal Chewable is contraindicated in individuals with a known hypersensitivity to any of the ingredients.
Viva® CT Prenatal Chewable is intended for use as a PRENATAL/POSTNATAL vitamin for lactating and non-lactating mothers. Talk with your medical practitioner to ensure adequate prenatal/postnatal supplementation. Consult with your licensed medical practitioner before using Viva® CT Prenatal Chewable if pregnant or nursing.
Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Viva® CT Prenatal Chewable is a prescription PRENATAL/POSTNATAL vitamin to be used only under licensed medical supervision.
Drugs which may interact with folate include:
**Folate is a broad term that includes folic acid and all reduced forms including I-methylfolate and folinic acid. Viva® CT Prenatal Chewable does not contain I-methylfolate or folinic acid but these warnings are included as general folate information.
Drugs which interact with vitamin B6:
Drugs which may interact with vitamin B12:
Allergic sensitization has been reported following both oral and parenteral administration of folate. Paresthesia, somnolence, nausea, and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.
Chew and swallow one tablet daily, or as directed by a licensed medical practitioner.
Store at Controlled Room Temperature 15°- 30°C (59°- 86°F). [See USP]. Dispense in a tight, light-resistant container.
Viva® CT Prenatal Chewable is supplied as round, light pink to pink-colored chewable tablets embossed VCT, and are dispensed in bottles of 30 tablets.
Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.
KEEP THIS OUT OF REACH OF CHILDREN.
All prescriptions using this product shall be pursuant to State statutes as applicable.
Manufactured by: Sancilio & Company, Inc.,
3874 Fiscal Court, Suite 200, Riviera Beach, FL 33404
MADE IN CHINA
folic acid, ferrous fumarate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, zinc oxide, cupric sulfate anhydrous, and selenomethionine tablet, chewable
|Labeler - JayMac Pharmaceuticals LLC (830767260)|