Label: CALCIUM FOLIC ACID PLUS D CHEWABLE- cholecalciferol, magnesium, boron, folic acid, pyridoxine, cyanocobalamin wafer
- NDC Code(s): 42192-706-60
- Packager: Acella Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated March 29, 2018
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- SPL UNCLASSIFIED SECTION
Description: Calcium-Folic Acid Plus D Chewable Wafers are a chewable Calcium and Folic Acid Formula with Vitamin D, Magnesium and other nutrients for the maintenance and support of special dietary needs of any individual where supplementation with the ingredients contained within would prove beneficial including: premenopausal, menopausal and postmenopausal patients pertaining to the loss of calcium or calcium deficit, as well as cardiovascular wellness managed through dietary therapy.
SUPPLEMENT FACTS Each Wafer Contains: Calcium Carbonate (Elemental 500 mg) 1342 mg Vitamin D 3 300 IU Magnesium 50 mg Boron 250 mcg Folic Acid 1 mg Vitamin B 6 10 mg Vitamin B 12 125 mcg
Other Ingredients: Fructose, Natural Cocoa Dutch Chocolate, Stearic Acid, Plasdone, Natural Chocolate Flavor, Magnesium Stearate, Acacia Gum, Silicon Dioxide.
INDICATIONS & USAGE
Indications and Usage: Calcium-Folic Acid Plus D Chewable Wafers are indicated, in addition to diet, to help satisfy the distinctive nutritional requirements of individuals under the supervision of a physician for the treatment of calcium deficiency, skeletal weakness and osteoporosis. Calcium-Folic Acid Plus D Chewable Wafers supplementation may be beneficial to individuals who have an insufficient dietary intake of the nutrients contained therein. Calcium and vitamin D supplementation may be useful in both preventing and treating osteoporosis. Vitamin D supplementation may be beneficial to those who are institutionalized and/or have reduced exposure to sunlight. Folic acid, vitamin B 6, and vitamin B 12, may help reduce the risk of cardiovascular disease by lowering blood levels of homocysteine. If dietary intake of calcium is inadequate, patients currently taking bisphosphonates for treatment of osteoporosis should be instructed to take calcium and vitamin D daily (Calcium-Folic Acid Plus D Chewable Wafers).
Contraindications: Calcium-Folic Acid Plus D Chewable Wafers are contraindicated in patients with hypersensitivity to any of its components. Calcium and vitamin D supplementation is contraindicated in those with hypercalcemia or conditions that may lead to hypercalcemia and those who form calcium containing stones are generally advised not to take supplemental calcium. Concomitant use of iron and calcium may inhibit the absorption of iron. Concomitant use of quinolones or tetracyclines with calcium may decrease the absorption of these medications. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. The use of folic acid doses above 1 milligram/day may precipitate or exacerbate the neurological damage of vitamin B 12 deficiency. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol and valproic acid.
- DRUG INTERACTIONS
- INFORMATION FOR PATIENTS
- PEDIATRIC USE
Adverse Reactions: Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Calcium-Folic Acid Plus D Chewable Wafers. However, allergic and/or idiosyncratic reactions to vitamins even at lower potencies or any ingredient are possible.
- DOSAGE & ADMINISTRATION
How Supplied: Brown-mottled, round shaped wafer, debossed on scored side with “BP 706”, plain on the other side. Calcium-Folic Acid Plus D Chewable Wafers are supplied in bottles of 60 wafers (42192-706-60). Store at room temperature, 15° - 30°C (59°- 86°F). Protect from light and moisture. The listed product number is not a National Drug Code, but has merely been formatted to comply with industry practice standard for pharmacy and insurance computer systems.
SPL UNCLASSIFIED SECTION
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
Acella Pharmaceuticals, LLC
Alpharetta, GA 30022
- PRINCIPAL DISPLAY PANEL - 60 wafers
INGREDIENTS AND APPEARANCE
CALCIUM FOLIC ACID PLUS D CHEWABLE
cholecalciferol, magnesium, boron, folic acid, pyridoxine, cyanocobalamin wafer
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-706 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 1342 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 300 [iU] MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM 50 mg BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON 250 ug FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 10 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 125 ug Inactive Ingredients Ingredient Name Strength FRUCTOSE (UNII: 6YSS42VSEV) COCOA (UNII: D9108TZ9KG) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE K29/32 (UNII: 390RMW2PEQ) MAGNESIUM STEARATE (UNII: 70097M6I30) ACACIA (UNII: 5C5403N26O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown Score 2 pieces Shape ROUND Size 25mm Flavor Imprint Code BP;706 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-706-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/20/2009 Labeler - Acella Pharmaceuticals, LLC (825380939) Establishment Name Address ID/FEI Business Operations Acella Pharmaceuticals, LLC 825380939 manufacture(42192-706)