::EVERETT

CalciFolic-DT Wafer is 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 B12 deficiency. High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid.

Precautions: 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.

Drug Interactions: As little as 5 mg of pyridoxine (vitamin B6) daily can decrease the efficacy of levodopa. Therefore, CalciFolic-DTT Wafer is not recommended for patients undergoing such therapy.

Information for Patients: CalciFolic-DT Wafer is a medical food for use only under the direction and supervision of a licensed physician. Total intakes of greater than 2,000 mg of calcium provide no added benefit to bone health.

Pregnancy: Shall only be administered under the supervision of a physician.

Pediatric: Not recommended for pediatric use.

Adverse Reactions : Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in CalciFolic-DT Wafer. However, allergic and/or idiosyncratic reactions to vitamins even at lower potencies or any ingredient are possible.

TUSSAFED-HCG Syrup is a Schedule III Controlled Substance. Because of the hydrocodone content, some abuse might be expected. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. It should be prescribed and administered with the degree of caution appropriate for this type of product.

In all cases of suspected overdose, immediately call your regional poison center and/or contact a physician immediately. Symptoms of overdosage may be caused by hydrocodone or phenylephrine. Hydrocodone may cause the classic narcotic symptoms of coma, pinpoint pupils of the eyes, and/or depressed respiration. The treatment of choice is naloxone hydrochloride administered in small intravenous doses (consult specific product labeling before use). Symptoms of overdosage with phenylephrine include anxiety, tenseness, respiratory difficulty, throbbing headache and awareness of the slow forceful heartbeat. Treatment is similar to that of an overdosage of epinephrine.

How Supplied : Brown-mottled, round shaped wafer, debossed on scored side with "EV 0068", plain on the other side

CalciFolic-DT Wafers are supplied in bottles of 60 wafers. NDC 0642-0068-60

Store at room temperature, 15-30ºC (59-86ºF). Protect from light and moisture.

Rx Only

Manufactured for:
Everett Laboratories, Inc., West Orange, NJ 07052

U.S. PATENT PENDING

7060	Rev. 10/06B

CalciFolic-DT

Description:

CalciFolic-DT Wafer is 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 and postmenopausal patients pertaining to the loss of calcium or calcium deficit, as well as cardiovascular wellness managed through dietary therapy.

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 (Boron Amino Acid Chelate)	250 mcg
Folic Acid	1.0 mg
Vitamin B6 (Pyridoxine HCl)	10 mg
Vitamin B12 (Cyanocobalamin)	125 mcg

Inactive Ingredients:

Fructose, Natural Cocoa Dutch Chocolate, Stearic Acid, Plasdone, Natural Chocolate Flavor, Magnesium Stearate, Acacia Gum, Silicon Dioxide.

Hydrocodone bitartrate is a potent antitussive which causes suppression of the cough reflex by a direct action on the cough center. Hydrocodone is approximately three times as potent as codeine on a weight basis, but has a higher addiction potential also. Phenylephrine hydrochloride is a sympathomimetic amine which acts predominantly on alpha receptors and has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation. Guaifenesin is an expectorant which exerts its action by stimulation of reflexes from the stomach and acts through the nauseant effect which increases the output from the secretory glands of the respiratory tract.

CalciFolic-DT Wafer is 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. CalciFolic-DT Wafer 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 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 biphosponates for treatment of osteoporosis should be instructed to take calcium and vitamin D daily (CalciFolic-DT).