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Advanced AM PM

TRIGEN Laboratories, Inc.

Advanced AM/PM Tablet & Capsule


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ADVANCED AM PM 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.

ADVANCED AM PM 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.

ADVANCED AM PM ADVERSE REACTIONS

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

ADVANCED AM PM 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

Advanced AM PM

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) NDC:13811-064
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:13811-064-12 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-07-13


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