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Encora AM Tablets, Encora Capsules, Encora PM Tablets (Ther-Rx)
DESCRIPTION
Encora™ is a prescription vitamin and mineral nutritional supplement with essential fatty acids consisting of two capsules and two tablets on each blister card designated for AM and PM oral administration as follows:
AM tablet is an oval-shaped, light pink film-coated tablet containing the following ingredients:
Calcium (calcium carbonate)400 mg
Vitamin D 3 (cholecalciferol)200 IU
Vitamin C (as Ester-C ® † )25 mg
Folic Acid, USP2 mg
Vitamin B 6 (pyridoxine hydrochloride, USP)25 mg
PM tablet is an oval-shaped, purple film-coated tablet containing the following ingredients:
Calcium (calcium carbonate)600 mg
Vitamin D 3 (cholecalciferol)600 IU
Vitamin C (as Ester-C ® † )25 mg
Folic acid, USP0.5 mg
Vitamin B 6 (pyridoxine hydrochloride, USP)12.5 mg
AM and PM capsule is a pink soft gelatin capsule containing the following ingredients:
Essential Fatty Acids (omega-3)650 mg
DHA and EPA550 mg ‡
a - Linolenic acid (ALA)100 mg
Linoleic acid (LA)10 mg
Vitamin E (dl-alpha-tocopheryl acetate)50 IU
† Ester-C ® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.
Ester-C ® is a licensed trademark of Zila Nutraceuticals, Inc.
‡ Eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA) ratio is approximately 2.7:1
Inactive Ingredients : Tablets: acacia, butylated hydroxyanisole, butylated hydroxytoluene, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C Red No. 27 aluminum lake, hydrolyzed gelatin, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide, and vegetable oil. The AM tablet also contains FD&C Blue No. 2 aluminum lake. The PM tablet also contains FD&C Blue No. 1 aluminum lake. Capsule: D&C Red No. 33, ethyl vanillin, FD&C Red No. 40, gelatin, glycerine, soybean oil and titanium dioxide.
INDICATIONS AND USAGE
Encora™ is a patented formulation indicated to provide calcium, essential fatty acids, folic acid and other vitamins and minerals for daily nutritional and health supplementation.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
Allergy Alert: This product contains soy.
PRECAUTIONS
General
Do not exceed recommended dosage. The calcium content should be considered before prescribing for patients with kidney stones. Encora™ should be used with caution in patients with known sensitivity or allergy to fish.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of this product did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, relfecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
Encora™ is a morning and evening oral dosing regimen, supplied in unit-dose blister cards each containing an AM dose of 1 soft gelatin capsule and 1 light pink tablet and a PM dose of 1 soft gelatin capsule and 1 purple tablet.
Encora™'s patented dosing regimen, consisting of an "AM" dose taken in the morning and a "PM" dose taken at night, should be followed for improved nutrient absorption potential, or as prescribed by your physician.
HOW SUPPLIED
Encora™ is supplied in a 30-day unit-of-use dispensing carton containing 30 blister cards of 2 tablets and 2 capsules each (NDC 64011-166-36).
Encora™ AM tablets are oval-shaped, light pink film-coated tablets, embossed "Ther-Rx" on one side and "147" with a partial bisect on the other side. The PM tablet are oval-shaped, purple film-coated tablets, debossed "Ther-Rx" on one side and "161" with a partial bisect on the other side. Encora™ capsules are pink soft gelatin capsules, imprinted "Ther-Rx 148" on one side in purple ink.
Store at controlled room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Avoid excessive heat above 40°C (104°F). Avoid freezing.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Mktd. by Ther-Rx Corp., St. Louis, MO 63044
U.S. Patent Nos. 4,822,816; 5,070,085; 5,945,123; 6,197,329; 6,214,379; 6,228,388; 6,258,846; 6,375,956; 6,576,666. Other U.S. Patents Pending.
P4889 05/05
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