Name of the medicinal product

Restor-F

Qualitative and quantitative composition

A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (poaceae). Folic acid (Restor-F) is used in the treatment and prevention of folate deficiencies and megaloblastic anemia. [PubChem]

Lecithin (Restor-F), a naturally occurring biochemical is also marketed as a commercial nutritional supplemental product. Lecithin (Restor-F) is being used for the treatment and/or prevention of neurological disorders, hepatic disorders and hyperlipidemia.

The USFDA has not studied the safety and efficacy of all commercial Lecithin (Restor-F) supplements. There may be toxic or contaminated products available over the market. The manufacturing standards of Lecithin (Restor-F) products are not known, and all supplements are not regulated by health agencies. Lecithin (Restor-F) should be purchased from a reliable source to avoid such problems.

Each 5 mL of syrup contains pure Taurine (Restor-F) 50 mg.

Each mL of infant drops contains pure Taurine (Restor-F) 50 mg, an amount comparable to that found in 1 L of human breast milk.

Vit B (Restor-F) contains specific active ingredients such as carnitine orotate and hepatic extract antitoxic fraction.

Each vial contains: Carnitine orotate 300 mg (equivalent to carnitine 152.4 mg and orotic acid 147.6 mg), carnitine HCl 184 mg (equivalent to carnitine base 150 mg), hepatic (liver) extract antitoxic fraction 25 mg (equivalent to cyanocobalamin 0.25 mcg), pyridoxine HCl (vitamin B₆) 25 mg, adenosine 5 mg, cyanocobalamin (vitamin B₁₂) 250 mcg.

Sometimes, there is color disproportion by physical properties during freeze-drying process but therapeutic effect is not affected.

Each teaspoonful (5 mL) of syrup contains vitamin C 83.33 mg, vitamin B1 8.33 mg, vitamin B6 1.67 mg, vitamin B12 8.33 mcg, riboflavin 4.16 mg, niacinamide 8.33 mg, dl-panthenol 3.33 mg, vitamin A 1500 units and vitamin D 100 units.

Therapeutic indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Provides nutritional dietary supplement for metabolic build-up & restores energy required for extra mental & physical activities. Stimulates appetite & promotes growth & proper development of brain, bones & muscles.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Folic acid (Restor-F) is used in the treatment and prevention of the folate deficiency state. It does not correct folate deficiency due to dihydrofolate reductase inhibitors. Folic acid (Restor-F) is also used in women of child-bearing potential and pregnant women to protect against neural tube defects in their offspring. It is also used for the treatment of folate-deficient megaloblastic anaemia, chronic haemolytic states such as thalassaemia major or sickle-cell anaemia.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Acute viral hepatitis, chronic hepatitis, alcoholic liver disease, cirrhosis of liver, prophylaxis & treatment of drug-induced hepatitis.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

peripheral vascular disorders

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Health food supplement to promote psychomotor development among infants and toddlers. To improve mental functioning and enhance memory of children. The child's partner in learning.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Multivit & lysine supplement for active growth, increased appetite, wt gain, enhanced body resistance to stress & infection.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Tab Prevention or treatment of Vit B (Restor-F)₁, B₆ & B₁₂ deficiencies. Forte tab Neuralgia, neuritis, diabetic neuropathy, sciatica, Vit B (Restor-F) deficiency, trigeminal neuralgia, intercostal neuralgia, hyperemesis gravidarum.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

For systemic use of Vit C (Restor-F): prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Zn supplement.

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Folic acid (Restor-F) (vitamin B 9) is necessary for strong blood.

Lack of Folic acid (Restor-F) may lead to anemia (weak blood). Your health care professional may treat this by prescribing Folic acid (Restor-F) for you.

Some conditions may increase your need for Folic acid (Restor-F). These include:

Alcoholism
Anemia, hemolytic
Diarrhea (continuing)
Fever (prolonged)
Hemodialysis
Illness (prolonged)
Intestinal diseases
Liver disease
Stress (continuing)
Surgical removal of stomach

In addition, infants smaller than normal, breast-fed infants, or those receiving unfortified formulas (such as evaporated milk or goat's milk) may need additional Folic acid (Restor-F).

Increased need for Folic acid (Restor-F) should be determined by your health care professional.

Some studies have found that Folic acid (Restor-F) taken by women before they become pregnant and during early pregnancy may reduce the chances of certain birth defects (neural tube defects).

Claims that Folic acid (Restor-F) and other B vitamins are effective for preventing mental problems have not been proven. Many of these treatments involve large and expensive amounts of vitamins.

Injectable Folic acid (Restor-F) is given by or under the direction of your health care professional. Another form of Folic acid (Restor-F) is available without a prescription.

Lecithin (Restor-F) is also known as lecithol, vitellin, kelecin, and granulestin. Lecithin (Restor-F) is a naturally occurring substance found in beef liver, steak, eggs, peanuts, cauliflower, and oranges. Commercial Lecithin (Restor-F) products usually come from soybeans, egg yolk, or brain tissue.

Lecithin (Restor-F) has been used in alternative medicine as an aid to treat high cholesterol, certain liver problems, gallbladder disease, or certain problems in people with mania. Lecithin (Restor-F) has also been used to prevent certain complications in in people who are unable to eat and are receiving nutrition through an IV (total parenteral nutrition, or TPN).

Lecithin (Restor-F) is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Not all uses for Lecithin (Restor-F) have been approved by the FDA. Lecithin (Restor-F) should not be used in place of medication prescribed for you by your doctor.

Lecithin (Restor-F) may also be used for purposes not listed in this product guide.

Bioflavonoids are found in the rind of green citrus fruits and in rose hips and black currants.

Bioflavonoids have been used in alternative medicine as an aid to enhance the action of vitamin C, to support blood circulation, as an antioxidant, and to treat allergies, viruses, or arthritis and other inflammatory conditions.

Not all uses for bioflavonoids have been approved by the FDA. Bioflavonoids should not be used in place of medication prescribed for you by your doctor.

Bioflavonoids is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Bioflavonoids may also be used for other purposes not listed in this product guide.

Not all uses for bioflavonoids have been approved by the FDA. Bioflavonoids should not be used in place of medication prescribed for you by your doctor.

Bioflavonoids is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Use bioflavonoids as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.

Dosage (Posology) and method of administration

1 cap daily.

Usual Adult Dose for Megaloblastic Anemia

1 mg orally, intramuscularly, subcutaneously or IV once a day. May continue until clinical symptoms of folate deficiency and the hematological profile have normalized.

Usual Adult Dose for Folic acid (Restor-F) Deficiency

400 to 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Women of childbearing age, pregnant, and lactating women: 800 mcg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Folic acid (Restor-F) Deficiency

Infant:

0.1 mg orally, intramuscularly, subcutaneously or IV once a day.

Child:

Less than 4 years: up to 0.3 mg orally, intramuscularly, subcutaneously or IV once a day.

4 years or older: 0.4 mg orally, intramuscularly, subcutaneously or IV once a day.

Usual Pediatric Dose for Vitamin/Mineral Supplementation

Recommended daily allowance (RDA):

Premature neonates: 50 mcg/day (15 mcg/kg/day).

Full-term neonates and infants 1 to 6 months: 25 to 35 mcg/day.

Children:

1 to 3 years: 150 mcg/day.

4 to 8 years: 200 mcg/day.

9 to 13 years: 300 mcg/day.

14 years and older: 400 mcg/day.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Rarely, a dosage of 2 mg/day may be required, particularly in patients with malabsorption, alcoholism, chronic hemolysis, chronic exfoliative skin disease or who are on concomitant anticonvulsant therapy.

Dialysis

Folic acid (Restor-F) is removed by both hemodialysis and peritoneal dialysis. The amount removed varies with type equipment used.

Because folate may accumulate in patients with end-stage renal disease, side effects may be more likely in this patient who is undergoing dialysis. Once this patient's body stores of folate are replete, three times a week dosing may be just as beneficial as once daily dosing but should portend a lower risk of side effects.

Other Comments

The recommended daily allowance of Folic acid (Restor-F) for adult males and females ranges from 150 to 200 and 150 to 180 mcg/day, respectively.

There is a potential danger in administering Folic acid (Restor-F) to patients with undiagnosed anemia, since Folic acid (Restor-F) may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress.

Severe megaloblastic anemia may require therapy for 4 to 5 weeks. Once stabilized, if dietary intake is inadequate, maintenance therapy can be started.

Oral

Dietary supplementation

Adult: 3-9 g daily in divided doses.

Syrup: Children 7-12 years: 5-10 mL (1-2 tsp); 2-6 years: 5 mL (1 tsp). All doses to be taken once a day.

Oral Drops:

Infants up to 2 years:

Childn 7-12 yr 15 mL, 3-6 yr 10 mL, 1-2 yr 5 mL. To be taken once daily.

Inject 2 vials/day through IV instillation after dissolving each vial of the freeze-dried cake with 4 mL water for injection.

Administration: Vit B (Restor-F) can be administered by LVP instillation process by diluting the solution to LVP solution. When using the LVP solution as diluent for Vit B (Restor-F) injection, it has to be cautioned that the LVP solution must be non-electrolyte LVP (eg, 5% dextrose solution). If the electrolyte-containing LVP solution (eg, Ringer's solution) is used, carnitine orotate will precipitate in the solution.

It is recommended that in the administration method, diluted LVP solution must be used because direct instillation without dilution can induce serious pain in the injection site.

As much as possible, inject slowly because blood vessel pain may occur during IV injection.

This medication administered orally, IM, IV, intravaginally.

For the prevention of deficiency conditions Vit C (Restor-F) dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.

For intravaginal used ascorbic acid drugs in appropriate dosage forms.

1 tab daily.

Contraindications

Because it may mask the hematologic abnormalities while neurological damage progresses, Folic acid (Restor-F) should not be used in the therapy of patients with vitamin B12 deficiency of any cause, unless there is associated folate deficiency. The Folic acid (Restor-F) content of one tablet a day however, is unlikely to mask pernicious anemia should this condition be present. Also, pregnancy during pernicious anemia is very rare.

hypersensitivty,

Hypersensitivity.

Hypersensitivity. Large doses (>1 g daily) of vit C in patients w/ G6PD deficiency. History of renal calculi, hyperoxaluria, oxalate dysbolism & thalassemia. Patients w/ Vit A (Restor-F) redundancy.

Hypersensitivity to any of the components of Vit B (Restor-F).

Increased sensitivity to ascorbic acid.

Special warnings and precautions for use

Use Folic acid (Restor-F) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Folic acid (Restor-F) may be administered as an injection by your health care professional.
If you are using Folic acid (Restor-F) at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial is cracked or damaged in any way, do not use it.
Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
If you miss a dose of Folic acid (Restor-F), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Folic acid (Restor-F).

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Folic acid (Restor-F) is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells.

Folic acid (Restor-F) supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of Folic acid (Restor-F) either through their diet or supplements to prevent infant spinal cord birth defects.

How to use Folic acid (Restor-F)

Take this product by mouth with or without food as directed by your doctor, usually once daily. If you are taking the over-the-counter product, follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.

Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this product more often than directed.

Take this product regularly to get the most benefit from it. To help you remember, take it at the same time each day. Follow the diet plan recommended by your doctor or dietician. See also Notes section.

If your condition persists or worsens, or if you think you may have a serious medical problem, get medical help right away.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Lecithin (Restor-F) is used as a health supplement to aid treatment of:

high blood levels of fats and cholesterol (hyperlipidemia and hypercholesterolemia).
liver problems due to fat accumulation (hepatic steatosis).
liver damage due to toxic effects (detoxification) of certain drugs (antituberculosis drugs, antipsychotics, antiepileptic drugs and immunosuppressant drugs).
problems of gallbladder.
certain neurological diseases such as mania (abnormally elevated mood), dementia (decline in memory and general mental ability).

Interaction with other medicinal products and other forms of interaction

Medications that interfere with your bodys ability to use folate may also increase the need for this vitamin. Medications can interfere with folate utilization, including: anticonvulsant medications (such as phenytoin, and primidone) metformin (sometimes prescribed to control blood sugar in type 2 diabetes) sulfasalazine (used to control inflammation associated with Crohns disease and ulcerative colitis) triamterene (a diuretic) Methotrexate There has been concern about the interaction between vitamin B12 and Folic acid (Restor-F). Folic acid (Restor-F) supplements can correct the anemia associated with vitamin B12 deficiency. Unfortunately, Folic acid (Restor-F) will not correct changes in the nervous system that result from vitamin B12 deficiency. Permanent nerve damage could theoretically occur if vitamin B12 deficiency is not treated. Therefore, intake of supplemental Folic acid (Restor-F) should not exceed 1000 micrograms (g, sometimes mcg) per day to prevent Folic acid (Restor-F) from masking symptoms of vitamin B12 deficiency. It is important for older adults to be aware of the relationship between Folic acid (Restor-F) and vitamin B12 because they are at greater risk of having a vitamin B12 deficiency. If you are 50 years of age or older, ask your physician to check your B12 status before you take a supplement that contains Folic acid (Restor-F).

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Vit E increases absorption of Vit A (Restor-F). Inhibits absorption & function of vit K w/ high doses of vit E. Reduced effects of vit E w/ Fe prep. Reduced absorption of Vit A (Restor-F) & E w/ cholestyramine & liqd paraffin.

High doses of Vit B (Restor-F)₆ may decrease the actions of L-dopa.

In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.

With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.

In an application of Vit C (Restor-F) with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.

Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.

Vit C (Restor-F) in an application with warfarin may decrease effects of warfarin.

With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.

In an application with tetracycline is increased excretion of ascorbic acid in the urine.

There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.

May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.

Undesirable effects

Allergic sensitization has been reported following both oral and parenteral administration of Folic acid (Restor-F).

Folic acid (Restor-F) is relatively nontoxic in man. Rare instances of allergic responses to Folic acid (Restor-F) preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic acid (Restor-F) daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic acid (Restor-F) therapy.

In an uncontrolled study, orally administered Folic acid (Restor-F) was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic acid (Restor-F) daily.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 844-740-7500.

Nausea, diarrhoea and increased salivation. Anorexia and hepatitis reported.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely to occur, and you may have none at all.

Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Nausea, vomiting, diarrhoea.

Long-term use of large doses of Vit B (Restor-F)₆ may lead to severe peripheral neuropathies.

CNS: headache, fatigue, insomnia.

Digestive system: stomach cramps, nausea and vomiting.

Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.

Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.

Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.