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.alpha.-tocopherol acetate, dl-,
zinc oxide and
cupric oxide tablet, chewable
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----------Vinate® Care Chewables
Each Vinate® Care Chewable Tablet Contains:
Vitamin C (1Ascorbic Acid and Threonic Acid) .........................................50 mg
Inactive Ingredients: Acacia, Carrageenan, Croscarmellose Sodium, Crospovidone, 2FD&C Yellow No. 6 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Orange Flavor, Polyvinylpyrrolidone, Silica, Starch, Stearic Acid, Sugar, Tartaric Acid, Unsaturated Mono & Diglycerides and Xylitol.
INDICATIONS AND USAGE
Vinate® Care Chewable tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period - for both lactating and non-lactating mothers. They are also useful for supplementing the nutritional status prior to conception.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
Safety and effectiveness in the pediatric population, under 12, have not been established.
No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and/or concomitant diseases, or other drug therapy.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
Usual dosage is one tablet daily, or as prescribed by a physician.
Do not exceed recommended dosage.
Vinate® Care Chewable tablets are available as orange, round concave-shaped tablets, debossed B 576. Supplied in bottles of 30 tablets, NDC 51991-576-33.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature.
Protect from light and moisture.
Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
PRINCIPAL DISPLAY PANEL
Revised: 01/2011 Breckenridge Pharmaceutical, Inc.
Reproduced with permission of U.S. National Library of Medicine
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