| |
|
|
 |
 |
To access specific portions of the Encora prescribing information, click on the following links.
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
Rx Only
Description |
|
| |
Encora® is a prescription vitamin and mineral nutritional supplement with omega-3 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 D3 (cholecalciferol).......................... |
200 IU |
|
| Vitamin C (as Ester-C®*)............................ |
25 mg |
|
| Folic Acid, USP............................................ |
2 mg |
|
| Vitamin B6 (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 D3 (cholecalciferol).......................... |
600 IU |
| Vitamin C (as Ester-C®*)............................ |
25 mg |
| Folic Acid, USP............................................ |
0.5 mg |
| Vitamin B6 (pyridoxine hydrochloride, USP)... |
12.5 mg |
| |
| AM and PM capsule is a pink soft gelatin capsule containing the following ingredients: |
| Omega-3 Fatty Acids (omega-3).................... |
650 mg |
| DHA and EPA.................................... |
550 mg† |
| α - 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 liscensed trademark of The Ester Company.
†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. |
| |
|
|
| Back to top |
|
|
| |
|
|
| 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. |
|
|
| |
|
|
| |
Back to top |
|
| |
|
|
| |
Contraindications |
|
| |
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. |
|
| |
|
|
| |
Back to top |
|
| |
|
|
| |
Warnings |
|
| |
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 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. |
|
| |
|
|
| |
Allegry Alert: This product contains soy. |
|
| |
|
|
| |
Back to top |
|
| |
|
|
| |
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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. |
|
| |
|
|
| |
Back to top |
|
| |
|
|
| |
Adverse Reactions |
|
| |
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. |
|
| |
|
|
| |
Back to top |
|
| |
|
|
| |
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. |
|
| |
|
|
| |
Back to top |
|
| |
|
|
| |
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, debossed “Ther-Rx” on one side and “147” with a partial bisect on the other side. The PM tablets 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; 6,479,545; 6,576,666; 7,112609. Other U.S. Patents Pending.
P4889-2 02/07 |
|
| |
|
|
| |
Back to top |
|
| |
|