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Medi-10

Generic Name: acetylcysteine, methyltetrahydrofolate, methylcobalamin, pyridoxal 5-phosphate, nicotinamide, cholecalciferol, chromium picolinate, alpha lipoic acid, coenzyme 10 and resveratrol
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Medi-10

Active Ingredients

 Ingredients Strength
 Acetylcysteine 200 mg
 Methyltetrahydrofolate(Vitamin B9) 2.5 mg
 Methylcobalamin (Vitamin B12) 2.5 mg
 Pyridoxal 5'-phosphate (Vitamin B6) 20 mg
 Nicotinamide (Vitamin B3) 10 mg
 Cholecalciferol (Vitamin D3) 1000 IU
 Chromium Picolinate 1 mg
 Alpha Lipoic Acid 200 mg
 Coenzyme Q10 16 mg
 Resveratrol 83 mg

Indication and Usage

Medi-10 capsule is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs where advanced folate supplementation is required or in management of endothelial dysfunction with diabetic peripheral neuropathy.


Medi-10 capsule can be prescribed as therapeutic nutritional supplementation in physiologically stressful conditions for maintenance of good health. It also supports healthy metabolism of glucose and carbohydrates.

Warnings and Precautions

Medi-10 capsules should be use only under the direction and supervision of a licensed physician.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Call your medical practitioner about side effects.

General:
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

Folate Regulation
The term "folates" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate.

Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12dependent methylation cycle.

Folic acid, including reduced forms* such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue.

The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that:
Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

Folic acid - including reduced forms, may be added to medical foods undefined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).

* It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.

Medi-10 capsule is not an antidepressant; however, folate has been shown to enhance antidepressant effects of known antidepressants. Caution is recommended in patients with a history of bipolar illness.

Drug Interactions:

Drug interactions with vitamin B6:
Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.


Drug interactions with folate:
• High dose folic acid may result in decreased serum levels for pyrimethamine and first-generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate).
• Folic acid may decrease a patient's response to methotrexate.
• 5-formyltetrahydrofolate may increase the toxicity of Capecitabine.

Drug interactions with vitamin B12:
• Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride may decrease the absorption of vitamin B12.
• Nitrous oxide can produce a functional vitamin B12 deficiency.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate.

Allergic reactions have been reported following the use of oral and parenteral vitamin B9.

Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine.
Paresthesia, somnolence, nausea and headaches have been reported with pyridoxal 5'-phosphate.

Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with methylcobalamin.

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Ask Doctor/Pharmacist:

Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product.

Pregnancy or Breast feeding:

Medi-10 capsule is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers.

This product contains a B vitamin in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

Keep out of reach of children:

Keep this out of the reach of children.

This product is not recommended for use in children under the age of twelve.

Dosage and Administration

Usual adult dose is one capsule once or twice in a day or as prescribed by licensed medical practitioner.

How supplied: 60 capsules dispensed in amber color bottle.

Storage and Handling

Store at controlled room temperature 20⁰C to 25⁰C (68⁰F to 77⁰F).

Protect from light and moisture. Dispense in a tight, light-resistant container.

Questions?

Call us at 800-494-7449

PRINCIPAL DISPLAY PANEL

Medi-10 
acetylcysteine, methyltetrahydrofolate, methylcobalamin, pyridoxal 5-phosphate, nicotinamide, cholecalciferol, chromium picolinate, alpha lipoic acid, coenzyme 10 and resveratrol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69589-004
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetylcysteine (ACETYLCYSTEINE) Acetylcysteine 200 mg
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 2.5 mg
Methylcobalamin (METHYLCOBALAMIN) Methylcobalamin 2.5 mg
PYRIDOXAL 5-PHOSPHATE (PYRIDOXAL 5-PHOSPHATE) PYRIDOXAL 5-PHOSPHATE 20 mg
niacinamide (NIACINAMIDE) niacinamide 10 mg
Cholecalciferol (CHOLECALCIFEROL) Cholecalciferol 1000 [iU]
Chromium Picolinate (CHROMIC CATION) CHROMIC CATION 1 mg
Alpha Lipoic Acid (.ALPHA.-LIPOIC ACID) Alpha Lipoic Acid 200 mg
UBIDECARENONE (UBIDECARENONE) UBIDECARENONE 16 mg
RESVERATROL (RESVERATROL) RESVERATROL 83 mg
Product Characteristics
Color purple Score no score
Shape capsule Size 24mm
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:69589-004-06 60 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2015
Labeler - Medicap laboratories Inc. (078798864)
Establishment
Name Address ID/FEI Operations
Medicap laboratories Inc. 078798864 wholesale drug distributor(69589-004)
Revised: 04/2015
 
Medicap laboratories Inc.



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