ADVANCED AM PM - calcium carbonate, cholecalciferol, ascorbic acid, folic acid, pyridoxine hcl, essential fatty acids, linolenic acid, dl-alpha-tocopheryl acetate   
TRIGEN Laboratories, Inc.

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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

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..

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.

CONTRAINDICATIONS

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

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.

ADVERSE REACTIONS

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

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.

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

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.

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.

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 08872
www.trigenlab.com

TRIGEN
LABORATORIES

Rev. 06/13

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
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 TypeItem Code (Source)NDC:13811-064
Packaging
#Item CodePackage Description
1NDC:13811-064-126 in 1 CARTON
11 in 1 BLISTER PACK
Quantity of Parts
Part #Package QuantityTotal 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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE400 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL200 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID2 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POTASSIUM CITRATE ANHYDROUS 
HYPROMELLOSES 
CITRIC ACID MONOHYDRATE 
POVIDONE K30 
ACACIA 
TITANIUM DIOXIDE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
POLYSORBATE 80 
SILICON DIOXIDE 
CORN OIL 
FD&C YELLOW No. 6 
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code MV007
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement07/13/2013
Part 2 of 3
ADVANCED PM 
calcium carbonate, cholecalciferol, ascorbic acid, folic acid and pyridoxine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE600 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL600 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID0.5 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
POTASSIUM CITRATE ANHYDROUS 
HYPROMELLOSES 
CITRIC ACID MONOHYDRATE 
POVIDONE K30 
ACACIA 
TITANIUM DIOXIDE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
STEARIC ACID 
TALC 
POLYSORBATE 80 
SILICON DIOXIDE 
CORN OIL 
FD&C BLUE No. 2 
PIGMENT RED 48 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize21mm
FlavorImprint Code MV008
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement07/13/2013
Part 3 of 3
ADVANCED AM PM 
omega-3, linolenic acid and dl-alpha-tocopherol capsule
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS650 mg
LINOLENIC ACID (LINOLENIC ACID) LINOLENIC ACID10 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL50 [iU]
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
WATER 
ETHYL VANILLIN 
Product Characteristics
ColorWhite (Clear) Scoreno score
ShapeCAPSULESize24mm
FlavorImprint Code
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement07/13/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Dietary Supplement07/13/2013
Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 07/2013
 
TRIGEN Laboratories, Inc.