ClearCOR Omega Fatty Acids

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                                                                     Fish Allergy:
                                                                     ClearCOR®-O3 Omega-3 Fatty Acids contains ethyl esters of

Omega-3 Fatty Acids
                                                                     omega-3 fatty acids (EPA and DHA) obtained from the oil of
                                                                     several fish sources.

SoftGels                                                             It is not known whether patients with allergies to fish and/or
                                                                     shellfish, are at increased risk of an allergic reaction to
                                                                     ClearCOR®-O3 Omega-3 Fatty Acids.
       is product is a Medical Food as defined in
    section 5(b) of the Orphan Drug Act (21 U.S.C.                   Use ClearCOR®-O3 Omega-3 Fatty Acids with caution in
    360ee(b)(3).      is product is intended to be used              patients with known hypersensitivity to fish and/or shellfish.
    based upon a physician’s medical evaluation and
                                                                     7 ADVERSE REACTIONS
    administered under the ongoing supervision of a
    physician. Its use is specifically for the dietary
                                                                     Adverse reactions may include mild gastrointestinal upset
    management of diseases or conditions with                        such as nausea, diarrhea, and flatulence. Additional adverse
    distinctive nutritional requirements based on                    reactions may include halitosis, eructation, and easy bruising
    recognized scientific principles.                                 due to blood thinning effects.
        is product is specifically formulated and
    processed for the partial feeding of a patient and               8 DRUG INTERACTIONS
    is intended for dietary management that cannot
                                                                     ClearCOR®-O3 Omega-3 Fatty Acids can prolong bleeding time.
    be achieved by the modification of the normal
    diet alone.
                                                                     Any person on ClearCOR®-O3 Omega-3 Fatty Acids and
    As determined by medical evaluation this                         anticoagulants or other drugs affecting coagulation (e.g. aspirin,
    product provides nutritional support specifically                 NSAIDS, or warfarin/coumadin) should have periodic monitoring
                                                                     by your physician.
    modified for the management of the patient’s
    unique nutrient needs resulting from a disease or                If you are using cholesterol-lowering medication (such as statins)
    condition and is intended to be sold and used                    consult your doctor before using ClearCOR®-O3 Omega-3 Fatty
    only under active and ongoing medical                            Acids.
    supervision on a recurring basis, for among other
    things, instructions on the use of this product.                 9 USE IN SPECIFIC POPULATIONS
       is product is not a prescription drug.
                                                                       • e effects of supplemental omega-3 fatty acids on
                                                                        reproductive capacity or fetal health has not been established.
                                                                       • Women taking ClearCOR®-O3 Omega-3 Fatty Acids should
1 USAGE                                                                  discontinue if they become pregnant.

ClearCOR®-O3 Omega-3 Fatty Acids (omega-3-acid ethyl                 Nursing Mothers:
esters) can help to maintain healthy cardiovascular function,         • Dietary intake of ClearCOR®-O3 Omega-3 Fatty Acids will
                                                                        result in higher levels of omega 3 fatty acids excreted in breast
immune system, and brain function. Regular use can also
have a favorable impact on cholesterol and triglyceride levels.
                                                                       • Women should discontinue ClearCOR®-O3 Omega-3 Fatty
Usage Considerations: Patients should be placed on an                    Acids while breastfeeding.
appropriate diet to optimize normal lipid levels before
receiving ClearCOR®-O3 Omega-3 Fatty Acids and should                Pediatrics:
continue this diet during supplementation.                             • e use of ClearCOR®-O3 Omega-3 Fatty Acids as a
                                                                        supplement is not recommended for persons less than 18 years
Attempts should be made in every person using                           old.
ClearCOR®-O3 Omega-3 Fatty Acids to also optimize
cardiovascular health with appropriated diet, exercise, weight       Geriatrics:
loss, smoking cessation, and controlling medical problems             • Safety and efficacy in persons older than 60 do not appear to
such as diabetes mellitus and high blood pressure.                      differ from persons under 60 years old.

2 DOSAGE AND ADMINISTRATION                                          10 OVERDOSAGE

During supplementation with ClearCOR®-O3 Omega-3 Fatty               Supportive measures under the supervision of a physician
Acids, persons should be placed on an appropriate diet to            should be undertaken in the event of an overdose.
achieve optimal cholesterol and triglyceride levels.
                                                                     11 DESCRIPTION
  e daily dose of ClearCOR®-O3 Omega-3 Fatty Acids is
2000-3000 mg per day.                                                ClearCOR®-O3 Omega-3 Fatty Acids, is supplied as a liquid-filled
                                                                     gel capsule for oral administration.
ClearCOR®-O3 Omega-3 Fatty Acids should be swallowed
whole.                                                               Each 1000 milligram capsule of ClearCOR®-O3 Omega-3 Fatty
                                                                     Acids contains at least 850 mg of the ethyl esters of omega-3 fatty
                                                                     acids sourced from fish oils.
                                                                     In ClearCOR®-O3 Omega-3 Fatty Acids the ethyl esters of
Dosage Form: Softgel capsule, liquid filled.                          omega-3 fatty acids are predominantly a combination of
                                                                     eicosapentaenoic acid (EPA 625 mg) and docosahexaenoic acid
4 TABLET FORMS AND STRENGTHS                                         (DHA 250 mg).

Do not break open, crush, dissolve, or chew capsules of              12 HOW SUPPLIED/STORAGE AND HANDLING
ClearCOR®-O3 Omega-3 Fatty Acids.
                                                                     ClearCOR®-O3 Omega-3 Fatty Acids is a 1000 milligram
ClearCOR®-O3 Omega-3 Fatty Acids (omega-3-acid ethyl esters)         transparent soft-gelatin capsule filled with light-yellow oil.
capsules are supplied as 1000 mg transparent soft-gelatin capsules
filled with light-yellow oil.                                         Store at termperatures between 59-86˚F (15-30˚C), preferrably in
                                                                     a cool, dry place and out of direct light.
                                                                     Keep out of reach of children.
ClearCOR®-O3 Omega-3 Fatty Acids should not be used by
any person with known hypersensitivity (e.g., anaphylactic           13 PATIENT COUNSELING INFORMATION
reaction) to ClearCOR®-O3 Omega-3 Fatty Acids or any of its
components.                                                          Use ClearCOR®-O3 Omega-3 Fatty Acids with caution in
                                                                     patients with sensitivity or allergy to fish or shellfish.
                                                                     ClearCOR®-O3 Omega-3 Fatty Acids should be used in
If you have liver problems, you should have periodic                 conjunction with a healthy diet and fitness program.
monitoring by your physician of liver enzymes alanine
aminotransferase (ALT) and aspartate aminotransferase (AST)          Persons should not alter ClearCOR®-O3 Omega-3 Fatty
levels while taking ClearCOR®-O3 Omega-3 Fatty Acids.
                                                                     Acids capsules in any way.
Total cholesterol, LDL cholesterol and triglyceride levels
should be monitored periodically by your physician while
                                                                     Manufactured for Alexander Labs
taking ClearCOR®-O3 Omega-3 Fatty Acids.                             2804 North Loop 289, Lubbock, TX 79415
                                                                     Call 877-410-5239 to report any adverse reactions.

                                                                     Revised August, 2010

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