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
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.
FULL PRESCRIBING INFORMATION
• 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.
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.
3 DOSAGE FORMS AND STRENGTH
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.
6 WARNINGS AND PRECAUTIONS
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