Generic Name: folate supplement
Dosage Form: tablet
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.
A Better Way
plus 50mg GPL-DHA
(3mg F-THF, 200mcg PteGlu CR, 400mcg Me-THF, 5mg NACA, 5mg PC-DHA , 2.5mg PE-DHA)
PRESCRIPTION (Rx) FOLATE / DIETARY SUPPLEMENT
IRON-FREE / B6-FREE
DESCRIPTION: Puralor® Ci* is an orally-administered prescription folate-containing product for the clinical dietary management of mild-to-moderate cognitive impairment disorders related to suboptimal folate levels associated with metabolic imbalances in transformylation and/or methylation biochemistry with particular emphasis on hyperhomocysteinemia and/or neurovascular oxidative stress.1
The protective effect of DeltaFolateTM in Puralor®Ci comes in supplying an array of folate-derivatives in combination with folate coenzymes, cofactors and co-metabolites that decrease the risk of bioavailability-interference such as might occur with inborn or environmental folate-malabsorption. This allows the folate substrate, THF, to be utilized in transformylation and/or methylation biochemistry.2,3,4
* Puralor® Ci may be taken by women of child bearing age. Puralor® Ci does not contain vitamin B6, and therefore has less risk of excessive dopamine production and antagonizing/agonizing dopamine-targeting drug therapies such as LevoDopa/CarbiDopa Parkinson’s Disease (PD). Furthermore, vitamin B12 and folate therapy have been shown to lower plasma homocysteine in L-DOPA-treated PD patients.5 Puralor® Ci also does not contain iron, and therefore has less risk of iron overload - a concern for elderly populations with or without neurodegenerative disorders.6
|a Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.|
|b DeltaFolate™ is a proprietary folate blend consisting of folinic acid, folic acid and methylfolic acid providing 3.6 mg of active vitamin B9 moiety.|
|cCitraFolic® is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration; it is patent pending.|
|d Omegga® GPL-DHA is a patent pending natural, egg yolk-derived omega-3 fatty acid derivative/phospholipid, and is a zwitterionic compound. The lipid, natural form is less prone to oxidation and/or first pass nutrient absorption interference. It has no added counter ion salts (such as would be found with krill or other refined phospholipid oils). It has the following two metabolic substrates:|
|1. PC-DHA as the active moiety phosphatidylcholine-docosahexaenoic acid, also known as 1-(MYRISTOYL, PALMITOYL, STEAROYL)-2-DOCOSA HEXAENOYL-SN-GLYCERO-3-PHOSPHOCHOLINE, and has the UNII code FF489C658A.|
|2. PE-DHA as the active moiety phosphatidylethanolamine-docosahexaenoic acid, also known as 1-(MYRISTOYL, PALMITOYL, STEAROYL)-2-DOCOSAHEXAENOYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE, and has the UNII code D98P995V9A.|
|INGREDIENTSa: Each oval, yellowish-orange-colored MULTIPHASIC tablet contains the following active dietary ingredients:|
|Omegga®'s GPL-DHAd* (50 mg) comprised of-
PC-DHA as phosphatidylcholine-docosahexaenoic acid
|PE-DHA as phosphatidylethanolamine-docosahexaenoic acid||2.5 mg|
|Phosphatidylcholine, phosphatidylethanolamine, other omegas/phospholipids/lecithins||42.5 mg|
|DeltaFolate™ (6mg) comprised of -
Folic acid (controlled-release citrated-pteroylmonoglutamic acidc, USP)
|Folinic acid (formyltetrahydrofolate)||3 mg|
|Methylfolic acid (levomefolate)||0.4 mg|
|Citrates (citric acid, sodium citrate)||2.4 mg|
|ALSO CONTAINSa The following distinct dietary ingredients as necessary cofactors, coenzymes and co-metabolites for advanced folate supplementation:|
|Magnesium Bisglycinate (1 mg elemental magnesium)||5 mg|
|NACA as n-acetyl-l-cystine amide||5 mg|
|L-ascorbic acid||25 mg|
|L-threonate magnesium||2.5 mg|
|Papaya proteinase I||20 mg|
|IF as intrinsic factor||2.5 mg|
EXCIPIENTS: [FUNCTIONAL] Citric acid, fumed silica, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, and tapioca starch [FLAVORINGS] artificial orange [SWEETENERS] sucralose, xylitol [COATINGS] orange coating (beta carotene, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, orange flavor, polyvinyl alcohol, polyethylene glycol, riboflavin, stevia, sucralose, talc, and titanium dioxide) [OTHER] r-5-formylTHF....[and other ancillary ingredientsh as needed to ensure product stability and/or manufacturing flow process quality].
US Patent Pending
h Contact with moisture may produce surface discoloration and/or erosion.
Puralor® Ci DOES NOT CONTAIN fish oil.
Puralor® Ci is third-party certified gluten-free.
ALLERGY STATEMENT: Puralor® Ci contains animal protein (bovine and porcine) and papaya protein. Puralor® Ci may contain casein. Puralor® Ci contains egg* This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.
* The omega-3 fatty acids in this product are derived from non-fish sources. Because the omega-3 fatty acids in this product are not derived from fish, they are essentially free of oceanic toxins commonly found in fish and also do not contain any EPA.
INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside Puralor® Ci . Folinic acid may enhance the toxicity of fluorouracil (see WARNINGS).
CONTRAINDICATIONS: Puralor® Ci is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. Puralor® Ci is contraindicated for individuals with conditions for which any of the Puralor® Ci ingredients are contraindicated.
WARNINGS: [PSYCHIATRY] Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population.
[ANTICONVULSANT] Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.
[GENERAL] Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.7
Individuals taking nitrates for the treatment of angina may experience severe headaches when taking NAC/NAC derivatives. Carbamazepine levels may be reduced when NAC is used with that drug.8 Patients at risk of developing renal stones, particularly cysteine stones, should avoid this product. Acetylcysteine clearance is reduced in preterm newborns as well as those with chronic liver disease. Do not administer to critically ill patients. Acetylcysteine and its sulfhydryl metabolites could produce a false-positive result in the nitroprusside test for ketone bodies used in diabetes. Acetylcysteine should be used with caution in those with a history of peptic ulcer disease since acetylcysteine may disrupt the gastric mucosal barrier.9
[ONCOLOGY] Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.
PRECAUTIONS: Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress.
Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral folate. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cobalamin. Nausea, vomiting, diarrhea, transient skin rash, flushing, epigastric pain, and constipation have been associated with acetylcysteine.
Call your medical practitioner about side effects. You may report side effects by calling (888) 886-2061.
OMEGA-3 ESSENTIAL FATTY ACIDS AND LECITHINS - Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are omega-3 fatty acids. The omega-3 fatty acid-derivatives in Puralor® Ci (as conjugated PC-DHA and conjugated PE-DHA/ “body ready” omega-3s) are uniquely conjugated to phospholipids – such as phosphatidylcholine (PC), which mimics the structure of fatty acids typically found in the healthy brain. Phospholipids are essential for neuronal and especially for synaptic structure and play key roles in the signal transduction responses to dopamine, serotonin, glutamate and acetylcholine. The unsaturated fatty acid components of phospholipids are abnormal in depression, with deficits of eicosapentaenoic acid and other omega-3 fatty acids.
Phosphatidylcholine-docosahexaenoic acid (PC-DHA) is the “body ready” derivative of DHA. Phosphatidylethanolamine-docosahexaenoic acid (PE-DHA) is the precursor to PC-DHA, and is a methylation-dependent process known as PE_methyltransferase (PEMTF) - which functions to sustain both PC synthesis in the liver and choline moiety production. Dopamine is involved in a receptor-mediated system. Specific nutrient deficiencies have been described in children with Attention Deficit Disorder including essential fatty acid derivatives. Higher levels of essential fatty acid derivatives improved cognitive performance in middle-aged adults.
FOLATE - Folate is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in folate-deficiency anemia. Folate is associated with methylation and transformylation biochemistry.45
Folates are best known for reducing the incidence of fetal neural tube defects (NTDs).45 NTDs are congenital malformations produced by failure of the neural tube to form and close properly during embryonic development.10 During the first four weeks of pregnancy - when many women do not even realize that they have conceived, adequate maternal folate intake is essential to reduce the risk of NTDs. As the postnatal period approaches there is increased demand again for folate regardless of lactation status. Folate is involved in transformylation and methylation metabolism as well as - indirectly, succinylation metabolism (through the “methyl trap” hypothesis). Folate plays a central role in the formation of nucleic acid precursors, such as thymidylic acid and purine nucleotides, which are essential for nucleic acid synthesis and cell division. IOM/NAS (1998) noted that the evidence for a protective effect from folate supplements is much stronger than that for food folate.11 Other dietary ingredients are added to folate as cofactors, coenzymes and co-metabolites; in studies by Czeizel and Dudas (1992) and Berry et al. (1999), factors other than folate intake may affect the magnitude of risk reduction or participate in a co-protective effect with folate.11
Puralor® Ci provides folate as DeltaFolate™ which contains:
FOLIC ACID CitraFolic® is a novel, controlled-release delivery method to optimize absorption of folic acid. CitraFolic® uses proprietary technology to encapsulate conventional folic acid, along with citrates, in controlled-release pellets. CitraFolic® is unique from conventional folic acid in that it: 1.) complies with USP requirements for folic acid dissolution. Some studies indicate that dissolution failure - that is, the failure of conventional folic acid supplements to meet USP requirements for dissolution - is a significant, concerning problem.12 2.) includes buffers to adjust the pH in order to remain soluble in a high acid environment, such as the gastric environment. This is important because folic acid must remain soluble in the acidic environment of the stomach in order to be absorbed in the intestine. Studies show that solubility of conventional folic acid decreases with increased acidity.13 Folic acid is converted into functional, metabolically active coenzyme forms for use in the body (61 Fed. Reg. at 8759-60), and supplies the active folate substrate, THF (tetrahydrofolate). Because the folate is controlled release (enteric coating delays 20 minutes then not less than 90% of folate is dissolved according to United States Pharmacopeia (USP) specifications within 60 minutes), it is less likely to interfere with heme iron (hemoglobin-derived iron) absorption as the body’s transport has a greater affinity for folic acid than for heme iron.47
FOLINIC ACID - Folinic acid plays an essential role in transformylation reactions, and is also the immediate precursor of L-5-MTHF substrate for B12-assisted methionine synthase which remethylates homocysteine to methionine. Folinic acid is a metabolically active folate, and does not require reduction by dihydrofolate reductase (DHFR). DHFR is an extremely slow enzyme with some individuals possessing lower than average activity. Studies of patients with cerebral folate deficiency have shown that oral folinic acid can bypass defective folate receptors and restore central nervous system folate levels. Low folate status is associated with impaired cognitive function.14 Folinic acid represents nearly 30% of natural folates. Folinic acid is converted into functional, metabolically active coenzyme forms for use in the body (61 Fed. Reg. at 8759-60), and supplies the active folate substrate, THF (tetrahydrofolate).
METHYLFOLIC ACID - About 70% of food folate and cellular folate is comprised of L-methylfolate. It is the primary form of folate in circulation, and is also the form transported across membranes - particularly across the blood brain barrier - into peripheral tissues. In the cell, L-methylfolate is used in the remethylation of homocysteine to form methionine and tetrahydrofolate (THF). Elevated levels of homocysteine may induce oxidative stress, leading to blood-brain barrier (BBB) dysfunction.15 L-methylfolate is converted into functional, metabolically active coenzyme forms for use in the body (61 Fed. Reg. at 8759-60), and supplies the active folate substrate, THF (tetrahydrofolate).
COENZYMES, COFACTORS AND CO-METABOLITES - The following dietary ingredients are added to enhance the bioavailable potential of folate, and include:
COBALAMIN - Cobalamin is required for two important reactions: the conversion of methylmalonyl CoA to succinyl CoA, a Krebs cycle intermediate, and the conversion of homocysteine to methionine, a reaction in which the methyl group of methyltetrahydrofolate is donated to remethylate homocysteine.45 Cobalamin deficiency, even in the absence of hematologic signs, may lead to impaired cognitive performance in adolescents. Decreased cobalamin status is strongly associated with cognitive dysfunction in the elderly.16 Many factors contribute to the cobalamin deficiency including diet, gastrointestinal pathology, autoimmune disease and medications.
VITAMIN D - Cholecalciferol is a form of vitamin D, also called vitamin D3. Vitamin D receptors are widespread in brain tissue, and vitamin D's biologically active form has shown neuroprotective effects. Associations have been noted between low vitamin D status and Alzheimer's disease and dementia in both Europe and the US.22 Vitamin D deficiency is seen frequently among the elderly.23,45
B VITAMINS - An association between inadequate vitamin B status and cognitive decline has been shown in studies. Mild subclinical vitamin deficiencies of niacin, thiamine, and riboflavin, are not uncommon in individuals with cognitive impairment.24 Emerging evidence suggests that thiamine deficiency produces alterations in brain function and structural damage that closely models a number of diseases in which neurodegeneration is a characteristic feature, including AD and PD; thus thiamine may have a role in AD and PD.25,45
COENZYME A - Coenzyme A is a precursor to acetyl-coenzyme A which is involved in synthesis and oxidation of fats.45
VITAMIN C - Vitamin C assists with folate metabolism. Studies also show that vitamin C may protect against cognitive impairment in some individuals.26
THREONATE - L-threonate magnesium is a highly absorbable form of threonic acid that is able to increase brain magnesium levels. Elevation of brain magnesium may prevent cognitive deficits.27 Magnesium deficiency can arise from diminished intake of magnesium, such as observed in malnutrition and starvation. Another cause of magnesium deficiency is excessive magnesium excretion, such as seen in uncontrolled diabetes, severe diarrheal states, malabsorption, and diuretic therapy. Magnesium deficiency may affect vitamin D absorption.
MAGNESIUM - Many neurodegenerative conditions have been reported to be associated with decreased brain magnesium levels17 and increased oxidative stress. Magnesium is an obligatory cofactor in glutathione synthesis. As a result, magnesium deficiency may impair glutathione synthesis. Magnesium concentrations have been shown to affect serotonin receptors, nitric oxide synthesis and release and NMDA receptors.18
NACA - N-acetyl-l-cysteine amide is the amide form of acetylcysteine - an amino acid derivative that has been shown to cross the blood-brain barrier. Acetylcysteine is a precursor to the antioxidant glutathione - the most prevalent circulating antioxidant. Oxidative stress has been implicated in cognitive disorders, such as mild cognitive impairment (MCI).28,29,45
ENZYME - Papaya proteinase I is a protein-cleaving enzyme derived from papaya.45 Papaya proteinase I may free cobalamin from unabsorbable cobalamin complexes (cobalamin-R-proteins) formed in situations of pancreatic insufficiency. Exocrine pancreatic dysfunction is associated with impaired ileal absorption of cobalamin.
INTRINSIC FACTOR - Intrinsic factor (IF) is a protein secreted by gastric parietal cells that facilitates absorption of cobalamin in the ileum. Once cobalamin is released into the intestinal lumen, it is taken up by intrinsic factor. The cobalamin-intrinsic factor complex is then absorbed by cells in the ileum, where the cobalamin is released and transported to the blood stream. Atrophic gastritis, reported to occur with a high prevalence in elderly patients, may result in decreased intrinsic factor secretion and consequently, impaired cobalamin absorption.30,45
FOLATE REGULATION: The Federal Register Notices from 1971 to 1973 established that increased folate was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood.32,33,34 Folate metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that “The agency concluded that the scientific literature did not support the superiority of any one source of folate over others, and that the data were insufficient to provide a basis for stating that a specific amount of folate is more effective than another amount [emphasis added].”35 The actual amount and source of folate require a licensed medical practitioner’s supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. 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. Oral preparations supplying more than 0.8 mg of folate per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated. When clinical symptoms have subsided and the blood picture and/or CSF folate levels have become normal, a maintenance level should be used. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added].”36 However, once the level of active folate exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a prescription (Rx)-folate / dietary supplement regardless of pregnancy/lactation status in spite of the fact that folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).37,38 In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote “... high intakes of folate may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added].”39 Summary: This product is a prescription (Rx) folate / dietary supplement product that - due to advanced folate levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.
INDICATIONS AND USAGE: Puralor® Ci is indicated for the distinct nutritional requirements of individuals who have suboptimal folates levels in the cerebrospinal fluid, plasma and/or red blood cells, and require a maintenance level. Folate is effective in the treatment of hyperhomocysteinemia and/or megaloblastic anemias40 (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin41, pregnancy, infancy, childhood or other related folate-malabsorption complications of an inborn or environmental origin.
Puralor® Ci is not a drug, but may be used as monotherapy (“rescue” therapy) or adjunctive therapy as determined by your licensed medical practitioner. The adjunctive use of Puralor® Ci enables medical practitioners to combine therapeutic modalities (dietary management and drug therapy). In patients with suboptimal folate levels - and as determined by your licensed medical practitioner, Puralor® Ci may be administered as rescue or adjunctive folate-therapy to provide a protective effect in reducing the risk of secondary/endpoints and/or disease-states of a hyperhomocysteinemia and/or vascular nature20 such as may be found with generalized and age-related cognitive decline, cognitive impairment, Vascular Dementia and/or Alzheimer's Disease (AD).
PREGNANCY AND NURSING MOTHERS: Puralor® Ci is a prescription (Rx)-folate containing product for nutritive supplementation for women of childbearing age who may become pregnant and/or are in need of increased folate levels in the central nervous system (CNS). Puralor® Ci may also be an appropriate folate supplement for those at high risk of NTDs because of the amount and diversity of folates. Puralor® Ci is Pregnancy Category A; however, Puralor® Ci is NOT a standard complete prenatal/postnatal supplement for the following reasons:
Puralor® Ci contains over 25,000% of DV of cobalamin for pregnant and lactating women.
Puralor® Ci contains over 450% of DV of folate for pregnant and lactating women, which may or may not be important depending upon your genetic disposition and previous pregnancies; please consult with your licensed medical practitioner on advanced folate supplementation during pregnancy for women at risk of NTDs and/or suboptimal folate/depression/postpartum.
Puralor® Ci contains NO IRON or Vitamin B6 (pyridoxine) --> which are very common nutrients found in prenatal/postnatal supplementation.
Puralor® Ci does not contain other vitamins and minerals that might be more suitable to your specific metabolic needs or part of a standard prenatal/postnatal multivitamin/multimineral/dietary supplement.7-9,10
GERIATRICS: Puralor® Ci is formulated for the clinical dietary management of cognitive impairment specifically related to suboptimal folate levels. Puralor® Ci does not contain iron.
DOSAGE AND ADMINISTRATION: SWALLOW one (1) tablet per day; or as directed by a licensed medical practitioner to achieve a satisfactory folate-maintenance level. Puralor® Ci may be taken with or without food but is preferred without. During times of medication transition the amount of Puralor® Ci may be increased as per direction of your licensed medical practitioner in order to achieve a “rescue” effect.
Puralor® Ci may also be administered by manually crushing a tablet, and then adding the contents to a thick juice or soft food - such as applesauce or yogurt. Puralor® Ci may be chewed. Chewable tablets can be a choking hazard to those who cannot chew, such as elderly persons.
HOW SUPPLIED: Puralor® Ci is supplied as orange-coated, orange citrus-flavored, round tablets debossed with “CLL” on one side, in bottles of 30 tablets with NDC†† 23359-700-30.
Puralor® Ci may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.
††This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) - or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications.
STORAGE: Store at room temperature, between 59°-77° F (15°- 25° C). Protect from light and moisture. Dispense in a tight, light-resistant container. Contact with moisture may produce surface discoloration and/or erosion.
MANUFACTURED FOR: Centurion Labs, LLC (Birmingham, Alabama, USA).
PATENTS: US Patent applications pending.
TRADEMARKS: Puralor® Ci is a registered trademark of Centurion Labs, LLC (Birmingham, Alabama, USA). Puralor® Ci was developed by Daniels-Trezza, LLC (Florida, USA). DeltaFolateTM is a use-trademark of Daniels-Trezza, LLC (Florida, USA). CitraFolic® and Omegga® are trademarks of Daniels-Trezza, LLC (Florida, USA).
REVISION: Sept 2014
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- The Federal Register Notice of April 9, 1971 (36 FR 6843).
- The Federal Register Notice of August 2, 1973 (38 FR 20750).
- The Federal Register Notice of October 17, 1980 (45 FR 69044).
- The Federal Register Notice of March 5, 1996 (61 FR 8760).
- The Federal Register Notice of August 2, 1973 (38 FR 20750).
- Code of Federal Regulations Title 21 Section 172.345.
- Code of Federal Regulations Title 21 Section 101.9(j)(8).
- Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
- Hallert C, Tobiasson P, Walan A. Serum folate determinations in tracing adult coeliacs. Scand J Gastroenterol. 1981;16:263-67.
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- Bonanomi L, Gazzaniga A. Toxicological, pharmacokinetic and metabolic studies on acetylcysteine. Eur J Respir Dis Suppl. 1980;111:45-51.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
A Better Way
plus 50mg GPL-DHA
(3mg F-THF, 200mcg PteGlu CR, 400mcg
Me-THF, 5mg NACA, 5mg PC-DHA , 2.5mg PE-DHA)
IRON-FREE / B6-FREE
Leading to Make Life Better
PRESCRIPTION (Rx) FOLATE / DIETARY SUPPLEMENT
30 MULTIPHASIC TABLETS
1-(c14-c18 esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphocholine, 1-(c14-c18 esteroyl)-2-docosahexanoyl-sn-glycero-3-phosphoethanolamine, egg phospholipids , folic acid, leucovorin, levomefolic acid, anhydrous citric acid, sodium citrate, magnesium glycinate, acetylcysteine amide, cholecalciferol, thiamine, riboflavin, pantethine, niacin, cobamamide, ascorbic acid, magnesium l-threonate, papain and intrinsic factor tablet, chewable
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