E-600 (Oral)

Vitamins are substances that your body needs for growth and health. You need them in small amounts, and they come from the foods you eat. Vitamin E helps prevent a process called oxidation, which can sometimes be harmful to your body. It is also important for the proper functioning of nerves and muscles.

Some conditions can increase your need for vitamin E. These include:

• Intestine disease
• Liver disease
• Pancreas disease
• Surgical removal of stomach

Your health care professional should determine if you need more vitamin E.

Infants who are on a formula that does not have added vitamin E may be at risk for a vitamin E deficiency. Additionally, diets that are high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E can treat cancer, prevent or treat acne, aging, hair loss, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcers, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. While vitamin E is used to try to prevent certain types of cancer, there is not enough evidence to show that it works.

A lack of vitamin E is very rare, except in people who have a condition that prevents it from being absorbed into the body.

Vitamin E is available without a prescription.

To be healthy, it's important to eat a balanced and varied diet. Follow any diet program recommended by your health care professional. If you think you are not getting enough vitamins and/or minerals in your diet, ask your health care professional for a list of appropriate foods or consider taking a dietary supplement.

Vitamin E can be found in various foods, including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storing these foods can reduce the amount of vitamin E they contain.

Vitamin supplements alone cannot replace a healthy diet and will not provide energy. Your body also needs other nutrients found in food, like protein, minerals, carbohydrates, and fats. Vitamins often need the presence of other foods to work properly. For example, some fat is necessary for your body to absorb vitamin E.

The daily amount of vitamin E you need is defined in different ways.

• For U.S.—
• Recommended Dietary Allowances (RDAs) are the amounts of vitamins and minerals needed for adequate nutrition in most healthy people. RDAs can vary depending on a person's age, sex, and physical condition (e.g., pregnancy).
• Daily Values (DVs) are found on food and dietary supplement labels to show the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous term United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed for adequate nutrition and to lower the risk of chronic disease.

Vitamin E comes in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E was expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit equals 1 mg of dl-alpha tocopherol acetate or 0.6 mg of d-alpha tocopherol. Many products sold in stores are still labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the needed vitamins some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with normal daily recommended amounts.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dicumarol

Using this dietary supplement with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With doses greater than 400 Units a day and long-term use

• Blurred vision
• diarrhea
• dizziness
• headache
• nausea or stomach cramps
• unusual tiredness or weakness

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Alpha-E
• Aqua Gem-E
• Aquasol E
• D-Alpha Gems
• E-400
• E-600
• E-Gems
• Formula E 400
• Gamma E-Gems
• Gamma E Plus
• Key-E
• Natural Vitamin Blend E-400IU
• Nutr-E-Sol

Available Dosage Forms:

• Tablet
• Solution
• Capsule, Liquid Filled
• Liquid
• Oil
• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral solution dosage form: To prevent the following deficiencies in infants: Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula. Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used. Infants of normal birthweight—5 Units per 32 ounces of formula.
• For oral dosage forms (capsules, tablets, oral solution): To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes: For the U.S. Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day. Adult and teenage females—8 mg alpha-TE or 13 Units per day. Pregnant females—10 mg alpha-TE or 16.7 Units per day. Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day. Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day. Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day. For Canada Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day. Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day. Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day. Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day. Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day. Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day. Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day. To treat deficiency: Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.
• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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