Label: ADVANCED AM PM - calcium carbonate, cholecalciferol, ascorbic acid, folic acid, pyridoxine hcl, essential fatty acids, linolenic acid, dl-alpha-tocopheryl acetate

  • NDC Code(s): 13811-064-12
  • Packager: TRIGEN Laboratories, Inc.
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated July 20, 2013

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Advanced AM/PM is a prescription vitamin and mineral nutritional supplement with essential fatty acids. Advanced AM tablets are oval-shaped, peach film-coated tablets, debossed “MVC007”. The PM tablets are oval-shaped, blue film-coated tablets, debossed “MVC008”. Advanced AM/PM capsules are clear soft gelatin capsules.

    Supplement Facts
    Servings per Carton: 30
    Serving Size: 1 Tablet and 1 SoftGel Capsule
    %DV Adults and Children
    4 Years or More
    AM Tablet (MVC007) AM Tablet (MVC007)
    Amount Per Serving %Daily Value %Daily Value
    Calcium(calcium carbonate)..... ....... 400 mg........ 40% ...... 600 mg........ 60%
    Vitamin D3(cholecalciferol) ......... ....... 200 IU........ 50% ...... 600 IU.......150%
    Vitamin C Complex*(as calcium ascorbate and calcium threonate) ....... 25 mg........ 42% ...... 25 mg........ 42%
    Folic Acid, USP......... ....... 2 mg........ 500% ...... 0.5 mg........ 125%
    Vitamin B6 (pyridoxine HCl, USP)...... ....... 25 mg...... 1250% ...... 12.5 mg.......625%
    AM and PM Softgel Capsule
    Amount Per Serving %Daily Value
    Essential Fatty Acids(omega-3)..... .......650 mg............ †
    DHA and EPA ............... ....550 mg**....... †
    a-Linolenic Acid (ALA) ........... ....100 mg ........... †
    Linolenic Acid(LA)..... .......10 mg............. †
    Vitamin E(dl-alpha-tocopheryl acetate).... ................50 IU....... 167%
    † Daily Values not established.
    * Vitamin C Complex is a pharmaceutical grade material consisting of calcium ascorbate and calcium threonate.
    *** Eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA) ratio is approximately 2.7:1
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  • STATEMENT OF IDENTITY

    Inactive Ingredients:

    Softgel:Gelatin, Glycerin, Purified Water, Ethyl Vanillin.

    AM Tablet:Microcrystalline Cellulose, TriPotassium Citrate, Hypromellose, Citric Acid, Povidone K30, Acacia, Titanium Dioxide,Croscarmellose Sodium, Magnesium Stearate, Polyethylene Glycol, Stearic Acid, Talc, Polysorbate 80, Fumed Silica, Vegetable Oil, FD&C Yellow #6.

    PM Tablet:Microcrystalline Cellulose, Hypromellose, TriPotassium Citrate, Croscarmellose Sodium, Povidone K30, Acacia, Titanium Dioxide, Citric Acid, Magnesium Stearate, Polyethylene Glycol, Stearic Acid, Talc, Polysorbate 80, Fumed Silica, Vegetable Oil, FD&C Blue #2, Carmine Hydrosoluble..

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  • INDICATIONS

    Advanced AM/PM is indicated to provide calcium, essential fatty acids, folic acid and other vitamins and minerals for daily nutritional and health supplementation.

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  • CONTRAINDICATIONS

    Advanced AM/PM is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • PRECAUTIONS

    General:

    Do not exceed recommended dosage. The calcium content should be considered before prescribing for patients with kidney stones. Advanced AM/PM should be used with caution in patients with known sensitivity or allergy to fish.

    Pediatric Use:

    Safety and effectiviness in pediatric patients have not been established.

    Geriatric Use

    Clinical studies of this product did not include sufficient numbers of subjects aged 65 or 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 concomitant disease or other drug therapy.

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  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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  • DOSAGE AND ADMINISTRATION

    Advanced AM/PM is a morning and evening oral dosing regimen, supplied in unit-dose blister cards each containing and AM dose of one (1) soft gelatin capsule and one (1) peach film-coated tablet and a PM dose of one (1) soft gelatin capsule and one (1) blue film-coated tablet.

    Advanced AM/PM 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.

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  • HOW SUPPLIED

    Advanced AM/PM is supplied in a 30-day unit-of-use dispensing carton containing 6 blister cards of AM dose and 6 blister cards of PM dose (5 doses per card, 1 tablet and 1 softgel per dose).

    PRODUCT CODE 13811-064-12

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  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. Avoid excessive above 40°C (104°F). Avoid freezing.

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  • 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 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

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  • PRECAUTIONS

    ALLERGY ALLERT: THIS PRODUCT CONTAINS SOY.

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  • PRECAUTIONS

    Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).

    KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

    Rx Only

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  • HEALTH CLAIM

    Manufactured for:
    TRIGEN Laboratories, Inc.
    Sayreville, NJ 08872
    www.trigenlab.com

    TRIGEN
    LABORATORIES

    Rev. 06/13

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  • PRINCIPAL DISPLAY PANEL - 60 Capsules and 60 Tablets Label

    TRIGEN
    LABORATORIES

    Advanced
    AM/PM

    Prescription Nutritional Suppliment
    With Essential Fatty Acids

    Rx Only
    13811-066-10

    30-Day Supply
    60 Capsules and 60 Tablets

    Principal Display Panel - 60 Capsules and 60 Tablets Label
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  • INGREDIENTS AND APPEARANCE
    ADVANCED AM PM 
    calcium carbonate, cholecalciferol, ascorbic acid, folic acid, pyridoxine hcl, essential fatty acids, linolenic acid, dl-alpha-tocopheryl acetate kit
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-064
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-064-12 6 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 60 
    Part 2 60 
    Part 3 60 
    Part 1 of 3
    ADVANCED AM 
    calcium carbonate, cholecalciferol, ascorbic acid, folic acid and pyridoxine hcl tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 400 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 200 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 2 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    ACACIA (UNII: 5C5403N26O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CORN OIL (UNII: 8470G57WFM)  
    FD&C YELLOW No. 6 (UNII: H77VEI93A8)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 07/13/2013
    Part 2 of 3
    ADVANCED PM 
    calcium carbonate, cholecalciferol, ascorbic acid, folic acid and pyridoxine hcl tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 600 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 600 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 0.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    ACACIA (UNII: 5C5403N26O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CORN OIL (UNII: 8470G57WFM)  
    FD&C BLUE No. 2 (UNII: L06K8R7DQK)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 07/13/2013
    Part 3 of 3
    ADVANCED AM PM 
    omega-3, linolenic acid and dl-alpha-tocopherol capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS 650 mg
    LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID 10 [iU]
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 50 [iU]
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 07/13/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 07/13/2013
    Labeler - TRIGEN Laboratories, Inc. (830479668)
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