Recal D

Generic Name: calcium carbonate, cholecalciferol, magnesium oxide, boric acid, folic acid, pyridoxine hydrochloride and cyanocobalamin
Dosage Form: chewable wafer

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.

Recal D WAFERS CHEWABLE WAFERS

INDICATIONS AND USAGE:

Recal D Wafers are indicated to help, along with diet, the treatment of calcium deficiency, skeletal weakness and osteoporosis. Recal D Wafers supplementation may be beneficial to individuals who have an insufficient dietary intake of the nutrients in this formulation. 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 B6 and vitamin B12 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 osteoporosis treatment should be instructed to take calcium and vitamin D daily.

DOSAGE AND ADMINISTRATION:

Chew one wafer twice daily or as prescribed by a physician.

DOSAGE FORMS AND STRENGTHS:

Recal D Wafers are supplied in bottles of 60 wafers, NDC 68032-270-60 and are brown, round shaped wafers, debossed on scored side with “RE 270.”

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CONTRAINDICATIONS:

Recal D Wafers are contraindicated in patients with hypersensitivity to any of its ingredients. 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. Used together, iron and calcium may inhibit the absorption of iron. Concurrent 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 one milligram per day may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs: carbamazepine, fosphenytoin, phenytoin, phenobarbital, valproic acid.

WARNINGS AND PRECAUTIONS:

Keep this and all medications out of the reach of children. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

ADVERSE REACTIONS:

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in Recal D Wafers. However, allergic and/or idiosyncratic reactions to vitamins even at lower potencies or any ingredient are possible.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DRUG INTERACTIONS:

As little as 5 mg of pyridoxine (vitamin B6) daily can decrease the efficacy of levodopa. Recal D Wafers are not recommended for patients undergoing levodopa therapy.

USE IN SPECIFIC POPULATIONS:

Pregnancy: Under the supervision of a physician only.
Pediatric Use: Not recommended for pediatric use.

DESCRIPTION:

Recal D Wafers are a chewable calcium and folic acid formula with Vitamin D, magnesium and other nutrients to help, along with diet, the treatment of calcium deficiency, skeletal weakness and osteoporosis. Recal D Wafers supplementation may be beneficial to individuals who have an insufficient dietary intake of the nutrients in this formulation. Calcium and vitamin D supplementation may be useful in both preventing and treating osteoporosis.

Each chocolate-flavored chewable wafer contains:
Active Ingredients:
Calcium Carbonate (Elemental 500mg)....................................1342 mg
Vitamin D3 (Cholecalciferol) ........................................................ 300 IU
Magnesium (Magnesium Oxide) .................................................50 mg
Boron ...................................................................................... 250 mcg
Folic Acid ....................................................................................1.0 mg
Vitamin B6 (Pyridoxine HCl) .........................................................10 mg
Vitamin B12 (Cyanocobalamin) ................................................ 125 mcg

Inactive Ingredients: Acacia, Aspartic Acid, Black Iron Oxide, Citric Acid, Chocolate Flavor, Croscarmellose Sodium, Dicalcium Phosphate, Glycine, Magnesium Stearate, Maltodextrin, Red Iron Oxide, Sodium Lauryl Sulfate, Soy Polysaccharide, Stearic Acid and Sugar.

HOW SUPPLIED:

Brown, round shaped wafer, debossed on scored side with “RE 270” in bottles of 60 wafers, NDC 68032-270-60.

Store at room temperature, 15-30°C (59-86°F). Protect from light and moisture.

Rx Only

Recal D  
calcium carbonate, cholecalciferol, magnesium oxide, boric acid, folic acid, pyridoxine hydrochloride, cyanocobalamin wafer
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-270
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 1342 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 300 [iU]
MAGNESIUM OXIDE (MAGNESIUM) MAGNESIUM OXIDE 50 mg
BORIC ACID (BORIC ACID) BORIC ACID 250 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 125 ug
Inactive Ingredients
Ingredient Name Strength
ACACIA  
ASPARTIC ACID  
FERROSOFERRIC OXIDE  
CITRIC ACID MONOHYDRATE  
CROSCARMELLOSE SODIUM  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
GLYCINE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
SODIUM LAURYL SULFATE  
SOYBEAN  
STEARIC ACID  
SUCROSE  
Product Characteristics
Color brown (RE 270) Score 2 pieces
Shape ROUND Size 23mm
Flavor Imprint Code RE;270
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-270-60 60 WAFER (WAFER) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/14/2009 10/31/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2011
 
River's Edge Pharmaceuticals, LLC



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