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 improv...
www.trigenlab.comAdvanced 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 |
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..
Advanced AM/PM is indicated to provide calcium, essential fatty acids, folic acid and other vitamins and minerals for daily nutritional and health supplementation.
Advanced AM/PM is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Safety and effectiviness in pediatric patients have not been established.
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.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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.
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
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.
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.
ALLERGY ALLERT: THIS PRODUCT CONTAINS SOY.
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
Manufactured for:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872www.trigenlab.com
TRIGEN
LABORATORIES
Rev. 06/13
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
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 13811-064-12 | EA - Each | 13811-064 | 49ec3c28-abd9-482c-9860-7312cc5000e2 | 1 | 2013-08-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| .ALPHA.-TOCOPHEROL | ACTIVE INGREDIENT | H4N855PNZ1 | 3 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 3 | |
| CALCIUM CARBONATE | ACTIVE INGREDIENT | H0G9379FGK | 3 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 3 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 3 | |
| LINOLENIC ACID | ACTIVE INGREDIENT | 0RBV727H71 | 3 | |
| OMEGA-3 FATTY ACIDS | ACTIVE INGREDIENT | 71M78END5S | 3 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 3 | |
| .ALPHA.-TOCOPHEROL | ACTIVE MOIETY | H4N855PNZ1 | 3 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 3 | |
| CALCIUM CATION | ACTIVE MOIETY | 2M83C4R6ZB | 3 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 3 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 3 | |
| LINOLENIC ACID | ACTIVE MOIETY | 0RBV727H71 | 3 | |
| OMEGA-3 FATTY ACIDS | ACTIVE MOIETY | 71M78END5S | 3 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 3 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 3 | |
| CARMINIC ACID | INACTIVE INGREDIENT | CID8Z8N95N | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 3 | |
| CORN OIL | INACTIVE INGREDIENT | 8470G57WFM | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| ETHYL VANILLIN | INACTIVE INGREDIENT | YC9ST449YJ | 3 | |
| FD&C BLUE No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 3 | |
| FD&C YELLOW No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 3 | |
| POTASSIUM CITRATE ANHYDROUS | INACTIVE INGREDIENT | 86R1NVR0HW | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13811-064 | 13811-064-12 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / RESPIRATORY (INHALATION) | 0.13 %w/w | ||
| ACACIA | ACACIA | 5C5403N26O | POWDER, FOR SOLUTION / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, SUGAR COATED / ORAL | NA | ||
| FD&C YELLOW No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 178 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM / SUBLINGUAL | 10 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| FD&C BLUE No. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, EXTENDED RELEASE / ORAL | 34.4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | PASTE / ORAL | 28 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, EXTENDED RELEASE / ORAL | 368 mg | ||
| FD&C YELLOW No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| ACACIA | ACACIA | 5C5403N26O | GUM, CHEWING / BUCCAL | 280 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, EXTENDED RELEASE / ORAL | 239 mg | ||
| FD&C YELLOW No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| ETHYL VANILLIN | ETHYL VANILLIN | YC9ST449YJ | PASTE / ORAL | 7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | ENEMA / RECTAL | 0.01 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | LOZENGE / ORAL | 700 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / INTRAVENOUS | 900 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FOR SUSPENSION / ORAL | 462 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| FD&C YELLOW No. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 127 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRA-ARTICULAR | 4 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, FILM COATED / ORAL | 57 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
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