Recal d wafer

Indications and usage:

RECAL D Wafers are indicated to help, along with diet, the treatment ofcalcium deficiency, skeletal weakness and osteoporosis. RECAL D Waferssupplementation may be beneficial to individuals who have aninsufficient dietary intake of the nutrients in this formulation.Calcium and vitamin D supplementation may be useful in both preventingand treating osteoporosis. Vitamin D supplementation may be beneficialto those who are institutionalized and/or have reduced exposure tosunlight. Folic acid, vitamin B6 and vitamin B12 may help reduce therisk of cardiovascular disease by lowering blood levels ofhomocysteine. If dietary intake of calcium is inadequate, patientscurrently taking bisphosphonates for osteoporosis treatment should beinstructed 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.

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, 15-30C (59-86F). Protect from light and moisture.

Rx Only

Ingredients and appearance - Product information

Recal d wafer- Calcium carbonate, cholecalciferol, magnesium oxide, boric acid, folic acid, pyridoxine hydrochloride, cyanocobalamin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68032-270
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Calcium carbonate ( UNII: H0G9379FGK)( Calcium - UNII: SY7Q814VUP ) 1342 mgin 1
Cholecalciferol ( UNII: 1C6V77QF41)( Cholecalciferol - UNII: 1C6V77QF41 ) 300 [iU]in 1
Magnesium oxide ( UNII: 3A3U0GI71G)( Magnesium - UNII: I38ZP9992A ) 50 mgin 1
Boric acid ( UNII: R57ZHV85D4)( Boric acid - UNII: R57ZHV85D4 ) 250 ugin 1
Folic acid ( UNII: 935E97BOY8)( Folic acid - UNII: 935E97BOY8 ) 1 mgin 1
Pyridoxine hydrochloride ( UNII: 68Y4CF58BV)( Pyridoxine - UNII: KV2JZ1BI6Z ) 10 mgin 1
Cyanocobalamin ( UNII: P6YC3EG204)( Cyanocobalamin - UNII: P6YC3EG204 ) 125 ugin 1

Inactive Ingredients

Ingredient Name Code
Acacia ( UNII: 5C5403N26O)
Aspartic acid ( UNII: 30KYC7MIAI)
Ferrosoferric oxide ( UNII: XM0M87F357)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Croscarmellose sodium ( UNII: M28OL1HH48)
Anhydrous dibasic calcium phosphate ( UNII: L11K75P92J)
Glycine ( UNII: TE7660XO1C)
Magnesium stearate ( UNII: 70097M6I30)
Maltodextrin ( UNII: 7CVR7L4A2D)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Soybean ( UNII: L7HT8F1ZOD)
Stearic acid ( UNII: 4ELV7Z65AP)
Sucrose ( UNII: C151H8M554)

Product Characteristics

Color brown (RE 270) Score 2
Shape ROUND Imprint Code RE;270
Size 23 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - River's Edge Pharmaceuticals, LLC( 133879135)

Package label.principal display panel