Label: OMEGA-3 RX COMPLETE kit

  • NDC Code(s): 60505-3170-7, 69176-190-30
  • Packager: TMIG, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated January 17, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • BOXED WARNING (What is this?)

    These highlights do not include all the information needed to use omega-3-acid ethyl esters capsules, USP
    safely and effectively. See full prescribing information for omega-3-acid ethyl esters capsules, USP. NDC 60505-3170-7.
    Also see full prescribing information of all package inserts inside product kit.

  • INDICATIONS & USAGE

    Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG)
    levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG).


    Usage Considerations : Patients should be placed on an appropriate lipid-lowering diet before
    receiving omega-3-acid ethyl esters capsules, USP and should continue this diet during treatment with
    omega-3-acid ethyl esters capsules, USP.


    Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before
    instituting therapy with omega-3-acid ethyl esters. Every attempt should be made to control serum lipids
    with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such
    as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications
    known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be
    discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.


    Limitations of Use:
    Sections or subsections omitted from the full prescribing information are not listed.
    The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been
    determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has
    not been determined.

  • DOSAGE & ADMINISTRATION

    As Always only take the prescribed dosages as per your physicans directions. 

    Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes
    mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate [see
    Indications and Usage (1)].


    Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl
    esters capsules, and should continue this diet during treatment with omega-3-acid ethyl esters
    capsules. In clinical studies, omega-3-acid ethyl esters capsules were administered with meals.

    The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day. The daily dose may be taken
    as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
    Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open,
    crush, dissolve, or chew omega-3-acid ethyl esters capsules.

    Dosage of Omeag-3 Support is 1-2 caps per day with food or as directed by your physician.

  • DOSAGE FORMS & STRENGTHS

    Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, soft gelatin capsules
    filled with light yellowish oil printed with white ink (Logo “APO900”).

    Omega-3 Support suppliment is as follows: 

    image description

  • CONTRAINDICATIONS

    Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g.,
    anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components.

  • WARNINGS AND PRECAUTIONS

    5.1 Monitoring: Laboratory Tests
    In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase
    (AST) levels should be monitored periodically during therapy with omega-3-acid ethyl esters capsules.
    In some patients, increases in ALT levels without a concurrent increase in AST levels were observed.
    In some patients, omega-3-acid ethyl esters capsule increases LDL-C levels. LDL-C levels should be
    monitored periodically during therapy with omega-3-acid ethyl esters.
    Laboratory studies should be performed periodically to measure the patient’s TG levels during therapy
    with omega-3-acid ethyl esters.


    5.2 Fish Allergy
    Omega-3-acid ethyl esters capsules contain ethyl esters of omega-3 fatty acids (EPA and DHA)
    obtained from the oil of several fish sources. It is not known whether patients with allergies to fish
    and/or shellfish, are at increased risk of an allergic reaction to omega-3-acid ethyl esters capsules.
    Omega-3-acid ethyl esters capsules should be used with caution in patients with known hypersensitivity
    to fish and/or shellfish.


    5.3 Recurrent Atrial Fibrillation (AF) or Flutter
    In a double-blind, placebo-controlled trial of 663 subjects with symptomatic paroxysmal AF (n=542) or
    persistent AF (n=121), recurrent AF or flutter was observed in subjects randomized to omega-3-acid
    ethyl esters who received 8 grams/day for 7 days and 4 grams/day thereafter for 23 weeks at a higher
    rate relative to placebo. Subjects in this trial had median baseline triglycerides of 127 mg/dL, had no
    substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control permitted), and
    were in normal sinus rhythm at baseline.


    At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or
    flutter events on placebo and 141 (53%) on omega-3-acid ethyl esters [primary endpoint, HR 1.19; 95%
    CI: 0.93, 1.35]. In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events
    on omega-3-acid ethyl esters [HR 1.63; 95% CI: 0.91, 2.18]. For both strata combined, the HR was 1.25;
    95% CI: 1.00, 1.40. Although the clinical significance of these results is uncertain, there is a possible
    association between omega-3-acid ethyl esters and more frequent recurrences of symptomatic atrial
    fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the
    first 2 to 3 months of initiating therapy.
    Omega-3-acid ethyl esters capsules are not indicated for the treatment of AF or flutter.

  • ADVERSE REACTIONS

    6.1 Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed
    in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another
    drug and may not reflect the rates observed in practice.
    Adverse reactions reported in at least 3% and at a greater rate than placebo for subjects treated with
    omega-3-acid ethyl esters capsules based on pooled data across 23 clinical trials are listed in Table 1.
    Table 1. Advers e Reactions Occurring at Incidence ≥3%
    and Greater than Placebo in Clinical Trials of omega-3-
    acid ethylesters capssules


    Adverse Reactions
    Omega-3-acid ethylesters capsules
    (N = 655)
    Placebo
    (N = 370)
    n % n %
    Eructation 29 4 5 1
    Dyspepsia 22 3 6 2
    Taste
    perversion 27 4 1 ≤1


    Additional adverse reactions from clinical trials are listed below:
    Digestive System: Constipation, gastrointestinal disorder and vomiting.
    Metabolic and Nutritional Disorders: Increased ALT and increased AST.
    Skin: Pruritus and rash.
    6.2 Pos tmarketing Experience
    In addition to adverse reactions reported from clinical trials, the events described below have been
    identified during post-approval use of omega-3-acid ethyl esters capsules. Because these events are
    reported voluntarily from a population of unknown size, it is not possible to reliably estimate their
    Trials included subjects with HTG and severe HTG.

    frequency or to always establish a causal relationship to drug exposure.
    The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.

  • DRUG INTERACTIONS

    Anticoagulants or Other Drugs Affecting Coagulation
    Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of
    bleeding time reported in these trials has not exceeded normal limits and did not produce clinically
    significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of
    omega-3-acid ethyl esters and concomitant anticoagulants. Patients receiving treatment with omega-3-
    acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents)
    should be monitored periodically.

  • USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy
    Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is
    unknown whether omega-3-acid ethyl esters capsules can cause fetal harm when administered to a
    pregnant woman or can affect reproductive capacity. Omega-3-acid ethyl esters capsules should be
    used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus.


    Animal Data: Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats
    when given in doses resulting in exposures 7 times the recommended human dose of 4 grams/day based
    on a body surface area comparison.
    In female rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day beginning 2 weeks prior to
    mating and continuing through gestation and lactation, no adverse effects were observed in the highdose
    group (5 times human systemic exposure following an oral dose of 4 grams/day based on body
    surface area comparison).


    In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg/kg/day from gestation day 6
    through 15, no adverse effects were observed (14 times human systemic exposure following an oral
    dose of 4 grams/day based on a body surface area comparison).
    In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day from gestation day 14
    through lactation day 21, no adverse effects were seen at 2,000 mg/kg/day (5 times the human systemic
    exposure following an oral dose of 4 grams/day based on a body surface area comparison). However,
    decreased live births (20% reduction) and decreased survival to postnatal day 4 (40% reduction) were
    observed in a dose-ranging study using higher doses of 3,000 mg/kg/day (7 times the human systemic
    exposure following an oral dose of 4 grams/day based on a body surface area comparison).


    In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg/kg/day from gestation day 7
    through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human
    systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).
    However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic
    exposure following an oral dose of 4 grams/day based on a body surface area comparison).

    8.3 Nursing Mothers
    Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this
    excretion on the infant of a nursing mother is unknown; caution should be exercised when omega-3-acid
    ethyl esters capsules are administered to a nursing mother. An animal study in lactating rats given oral
    gavage C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk 14 than in plasma.


    8.4 Pediatric Use
    Safety and effectiveness in pediatric patients have not been established.


    8.5 Geriatric Use
    A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid
    ethyl esters capsules. Safety and efficacy findings in subjects older than 60 years did not appear to
    differ from those of subjects younger than 60 years.

  • DRUG ABUSE AND DEPENDENCE

    Omega-3-acid ethyl esters capsules do not have any known drug abuse or withdrawal effects.

  • DESCRIPTION

    Omega-3-acid ethyl esters capsules, USP, a lipid-regulating agent, are supplied as a liquid-filled gel
    capsule for oral administration. Each 1-gram capsule of omega-3-acid ethyl esters capsules, USP
    contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are
    predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and
    docosahexaenoic acid (DHA - approximately 375 mg).


    The molecular formula of EPA ethyl ester is C H O , and the molecular weight of EPA ethyl ester is
    330.51.


    The molecular formula of DHA ethyl ester is C H O , and the molecular weight of DHA ethyl ester
    is 356.55.


    Omega-3-acid ethyl esters capsules, USP also contain the following inactive ingredients: 4 mg α-
    tocopherol (in a carrier of soybean oil), and gelatin, glycerin, purified water, and white ink (components
    of the capsule shell). The capsule imprinting ink contains ammonium hydroxide, propylene glycol,
    shellac glaze, simethicone and titanium dioxide.

  • CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action
    The mechanism of action of omega-3-acid ethyl esters is not completely understood. Potential
    mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased
    mitochondrial and peroxisomal β-oxidation in the liver, decreased lipogenesis in the liver, and
    increased plasma lipoprotein lipase activity. Omega-3-acid ethyl esters may reduce the synthesis of
    triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for
    TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.


    12.3 Pharmacokinetics
    In healthy volunteers and in subjects with hypertriglyceridemia, EPA and DHA were absorbed when
    administered as ethyl esters orally. Omega-3-acids administered as ethyl esters induced significant,
    dose-dependent increases in serum phospholipid EPA content, though increases in DHA content were
    less marked and not dose-dependent when administered as ethyl esters.
    Specific Populations: Age: Uptake of EPA and DHA into serum phospholipids in subjects treated with
    omega-3-acid ethyl esters was independent of age (<49 years versus ≥49 years).
    Gender: Females tended to have more uptake of EPA into serum phospholipids than males. The clinical
    significance of this is unknown.


    Pediatric: Pharmacokinetics of omega-3-acid ethyl esters have not been studied.
    Renal or Hepatic Impairment: Omega-3-acid ethyl esters has not been studied in patients with renal or
    hepatic impairment.
    Drug-Drug Interactions:Simvastatin: In a 14-day trial of 24 healthy adult subjects, daily coadministration
    of simvastatin 80 mg with omega-3-acid ethyl esters 4 grams did not affect the extent (AUC) or rate
    (C ) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin at steady
    state.
    Atorvastatin: In a 14-day trial of 50 healthy adult subjects, daily coadministration of atorvastatin 80 mg
    with omega-3-acid ethyl esters 4 grams did not affect AUC or C of exposure to atorvastatin, 2-
    hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.
    Rosuvastatin: In a 14-day trial of 48 healthy adult subjects, daily coadministration of rosuvastatin 40 mg
    with omega-3-acid ethyl esters 4 grams did not affect AUC or C of exposure to rosuvastatin at
    steady state.


    In vitro studies using human liver microsomes indicated that clinically significant cytochrome P450-
    mediated inhibition by EPA/DHA combinations are not expected in humans.

  • NONCLINICAL TOXICOLOGY

    13.1 Carcinogenes is , Mutagenes is , Impairment of Fertility
    In a rat carcinogenicity study with oral gavage doses of 100, 600, and 2,000 mg/kg/day, males were
    treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an increased
    incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4 grams/day
    based on a body surface area comparison). Standard lifetime carcinogenicity bioassays were not
    conducted in mice.


    Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in
    the bacterial mutagenesis (Ames) test with Salmonella typhimurium and Escherichia coli or in the
    chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid
    ethyl esters were negative in the in vivo mouse micronucleus assay.
    In a rat fertility study with oral gavage doses of 100, 600, and 2,000 mg/kg/day, males were treated for
    10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating,
    gestation, and lactation. No adverse effect on fertility was observed at 2,000 mg/kg/day (5 times human
    systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).

  • CLINICAL STUDIES

    14.1 Severe Hypertriglyceridemia
    The effects of omega-3-acid ethyl esters 4 grams per day were assessed in 2 randomized, placebomax
    controlled, double-blind, parallel-group trials of 84 adult subjects (42 on omega-3-acid ethyl esters, 42
    on placebo) with very high triglyceride levels. Subjects whose baseline triglyceride levels were
    between 500 and 2,000 mg/dL were enrolled in these 2 trials of 6 and 16 weeks' duration. The median
    triglyceride and LDL-C levels in these subjects were 792 mg/dL and 100 mg/dL, respectively. Median
    HDL-C level was 23.0 mg/dL.


    The changes in the major lipoprotein lipid parameters for the groups receiving omega-3-acid ethyl
    esters or placebo are shown in Table 2. (Refer to actual table in package insert in product )
    Table 2. Median Baseline and Percent Change From Baseline in Lipid
    Parameters in Subjects With Severe Hypertriglyceridemia (≥500 mg/dL)
    Parameter
    Omega-3-acid ethyl esters
    N = 42
    Placebo
    N = 42 Difference
    BL % Change BL % Change
    TG 816 -44.9 788 +6.7 -51.6
    Non-HDL-C 271 -13.8 292 -3.6 -10.2
    TC 296 -9.7 314 -1.7 -8.0
    VLDL-C 175 -41.7 175 -0.9 -40.8
    HDL-C 22 +9.1 24 0.0 +9.1
    LDL-C 89 +44.5 108 -4.8 +49.3


    BL = Baseline (mg/dL); % Change = Median Percent Change from Baseline; Difference = omega-3-acid
    ethyl esters Median % Change - Placebo Median % Change.
    Omega-3-acid ethyl esters 4 grams per day reduced median TG, VLDL-C, and non-HDL-C levels and
    increased median HDL-C from baseline relative to placebo. Treatment with omega-3-acid ethyl esters
    to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals.
    Patients should be monitored to ensure that the LDL-C level does not increase excessively.
    The effect of omega-3-acid ethyl esters on the risk of pancreatitis has not been determined.
    The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been
    determined.

  • HOW SUPPLIED

    Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, oblong soft gelatin
    capsules with light yellowish oil printed with white ink (Logo “APO900”).


    They are supplied as follows:
    Bottles of 30s (NDC 60505-3170-3)
    Bottles of 60s (NDC 60505-3170-6)
    Bottles of 120s (NDC 60505-3170-7)


    Store in tight, light-resistant containers at 25°C (77°F); excursions permitted to 15° to 30°C (59° to
    86°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach
    of children.

    Omega-3 Support vitamin and mineral suppliment are supplied capsules

    They are supplied in bottles of 60 ( 69176-190-10) 

  • PATIENT MEDICATION INFORMATION

    Advise the patient to read the FDA-approved patient labeling (Patient Information).
    Information for Patients:
    Omega-3-acid ethyl esters capsules should be used with caution in patients with known sensitivity or
    allergy to fish and/or shellfish [see Warnings and Precautions (5.2)].


    Advise patients that use of lipid-regulating agents does not reduce the importance of adhering to
    diet [see Dosage and Administration (2)].


    Advise patients not to alter omega-3-acid ethyl esters capsules in any way and to ingest intact
    capsules only [see Dosage and Administration (2)].


    Instruct patients to take omega-3-acid ethyl esters capsules as prescribed. If a dose is missed,
    advise patients to take it as soon as they remember. However, if they miss one day of omega-3-acid
    ethyl esters capsules, they should not double the dose when they take it.


    APOTEX INC.
    Omega-3-Acid Ethyl Esters Capsules , USP
    1 gram


    Manufactured by:
    Accucaps Industries Limited
    Windsor, Ontario
    Canada N9C 3R5


    Manufactured for:
    Apotex Corp.
    Weston, Florida
    USA 33326
    Revision: 4
    Revised: May 2014

    Omega-3-Acid Ethyl Es ters
    (oh-may-ga-as -id-eth-il-es -ters )
    Caps ules , USP


    Read this Patient Information before you start taking omega-3-acid ethyl esters capsules, and each time
    you get a refill. There may be new information. This information does not take the place of talking with
    your doctor about your medical condition or your treatment.


    What are omega-3-acid ethyl es ters capsules ?
    Omega-3-acid ethyl esters capsules are a prescription medicine used along with a low fat and low
    cholesterol diet to lower very high triglyceride (fat) levels in adults.
    It is not known if omega-3-acid ethyl esters capsules change your risk of having inflammation of your
    pancreas (pancreatitis).


    It is not known if omega-3-acid ethyl esters capsules prevent you from having a heart attack or stroke.
    It is not known if omega-3-acid ethyl esters capsules are safe and effective in children.
    Who s hould not take omega-3-acid ethyl es ters capsules ?


    Do not take omega-3-acid ethyl esters capsules if you are allergic to omega-3-acid ethyl esters or any
    of the ingredients in omega-3-acid ethyl esters capsules. See the end of this leaflet for a complete list
    of ingredients in omega-3-acid ethyl esters capsules.


    What s hould I tell my doctor before taking omega-3-acid ethyl esters capsules ?
    Before you take omega-3-acid ethylesters capsules , tell your doctor if you:
    have diabetes.
    have a low thyroid problem (hypothyroidism).
    have a liver problem.
    have a pancreas problem.
    have a certain heart rhythm problem called atrial fibrillation or flutter.
    are allergic to fish or shellfish. It is not known if people who are allergic to fish or shellfish are
    also allergic to omega-3-acid ethyl esters capsules.
    are pregnant or plan to become pregnant. It is not known if omega-3-acid ethyl esters capsules will
    harm your unborn baby.
    are breastfeeding or plan to breastfeed. Omega-3-acid ethyl esters can pass into your breast milk.
    You and your doctor should decide if you will take omega-3-acid ethyl esters capsules or
    breastfeed.


    Tell your doctor about all the medicines you take, including prescription and non-prescription medicine,
    vitamins, and herbal supplements.
    Omega-3-acid ethyl esters capsules can interact with certain other medicines that you are taking. Using
    omega-3-acid ethyl esters capsules with medicines that affect blood clotting (anticoagulants or blood
    thinners) may cause serious side effects.
    Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a
    new medicine.

    How s hould I take omega-3-acid ethyl esters capsules ?
    Take omega-3-acid ethyl esters capsules exactly as your doctor tells you to take it.

    You should not take more than 4 capsules of omega-3-acid ethyl esters capsules each day.

    Either take all 4 capsules at one time, or 2 capsules two times a day.
    Do not change your dose or stop omega-3-acid ethyl esters capsules without talking to your doctor.
    Take omega-3-acid ethyl esters capsules with or without food.
    Take omega-3-acid ethyl esters capsules whole. Do not break, crush, dissolve, or chew omega-3-
    acid ethyl esters capsules before swallowing. If you cannot swallow omega-3-acid ethyl esters
    capsules whole, tell your doctor. You may need a different medicine.
    Your doctor may start you on a diet that is low in saturated fat, cholesterol, carbohydrates, and low
    in added sugars before giving you omega-3-acid ethyl esters capsules. Stay on this diet while taking
    omega-3-acid ethyl esters capsules.


    Your doctor should do blood tests to check your triglyceride, bad cholesterol and liver function
    levels while you take omega-3-acid ethyl esters capsules.
    What are the pos s ible s ide effects of omega-3-acid ethyl es ters caps ules ?
    Omega-3-acid ethyl es ters caps ules may caus e s erious s ide effects , including:
    increases in the results of blood tests used to check your liver function (ALT and AST) and your
    bad cholesterol levels (LDL-C).
    increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially
    happen in the first few months of taking omega-3-acid ethyl esters capsules if you already have that
    problem.


    The most common side effects of omega-3-acid ethyl esters capsules include:
    burping
    upset stomach
    a change in your sense of taste
    Talk to your doctor if you have a side effect that bothers you or does not go away.
    These are not all the possible side effects of omega-3-acid ethyl esters capsules. For more
    information, ask your doctor or pharmacist.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-
    FDA-1088.


    How s hould I s tore omega-3-acid ethylesters capsules ?

    Store omega-3-acid ethyl esters capsules at room temperature, 59° to 86° F (15° to 30° C). Protect
    from light.
    Do not freeze omega-3-acid ethyl esters capsules.
    Safely throw away medicine that is out of date or no longer needed.
    Keep omega-3-acid ethyl es ters caps ules and all medicines out of the reach of children.
    General information about the s afe and effective us e of omega-3-acid ethyl es ters caps ules
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
    Do not use omega-3-acid ethyl esters capsules for a condition for which it was not prescribed. Do not
    give omega-3-acid ethyl esters capsules to other people, even if they have the same symptoms you
    have. It may harm them.


    This Patient Information Leaflet summarizes the most important information about omega-3-acid ethyl
    esters capsules. If you would like more information, talk with your doctor. You can ask your doctor or
    pharmacist for information about omega-3-acid ethyl esters capsules that is written for health
    professionals.
    For more information go to www.apotex.com or call 1-800-706-5575.


    What are the ingredients in omega-3-acid ethyl esters capsules ?
    Active Ingredient: omega-3-acid ethyl esters, mostly EPA and DHA
    Inactive Ingredients: alpha-tocopherol (in soybean oil), gelatin, glycerin, purified water and white
    ink. The capsule imprinting ink contains ammonium hydroxide, propylene glycol, shellac glaze,
    simethicone and titanium dioxide.
    This patient labeling has been approved by the U.S. Food and Drug Administration.
    APOTEX INC.
    Omega-3-Acid Ethyl Es ters Caps ules , USP
    1 gram
    Manufactured by:
    Accucaps Industries Limited
    Windsor, Ontario
    Canada N9C 3R5
    Manufactured for:
    Apotex Corp.
    Weston, Florida
    USA 33326
    Revision: 4
    Revised: May 2014

  • PRINCIPAL DISPLAY PANEL

    Omega-3 RX Complete

    Omega-3 Support

  • INGREDIENTS AND APPEARANCE
    OMEGA-3 RX COMPLETE 
    omega-3 rx complete kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69176-190
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69176-190-301 in 1 BOX; Type 0: Not a Combination Product09/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 CAPSULE
    Part 21 BOTTLE
    Part 1 of 2
    OMEGA-3 SUPPORT 
    omega-3 support capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A3500 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D700 [iU]
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-22.5 [iU]
    PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE.020 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.35 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE18 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID.4 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN.018 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN.075 mg
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID.016 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM210 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION140 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM.11 mg
    copper (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) copper2 mg
    MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM140 mg
    CHROMIUM NICOTINATE (UNII: A150AY412V) (NIACIN - UNII:2679MF687A) CHROMIUM NICOTINATE.12 mg
    LYCOPENE (UNII: SB0N2N0WV6) (LYCOPENE - UNII:SB0N2N0WV6) LYCOPENE.3 mg
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeCAPSULESize8mm
    FlavorImprint Code blank
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT09/01/2015
    Part 2 of 2
    OMEGA-3-ACID ETHYL ESTERS 
    omega-3-acid ethyl esters capsule, liquid filled
    Product Information
    Item Code (Source)NDC:60505-3170
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3-ACID ETHYL ESTERS1 g
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    Coloryellow (light yellow) Scoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code APO900
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60505-3170-71 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09097309/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09097309/01/2015
    Labeler - TMIG, Inc. (036572986)
    Registrant - TMIG, Inc. (036572986)
    Establishment
    NameAddressID/FEIBusiness Operations
    EPM Packaging079124340repack(69176-190)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc.205576023manufacture(60505-3170)