E-400 (Oral)

Vitamins are essential substances that your body needs for growth and health. You only need them in small amounts, and you can get them from the foods you eat. Vitamin E helps prevent a process called oxidation, which can sometimes cause harm to your body. It is also important for your nerves and muscles to work properly.

Some health conditions may increase how much vitamin E you need. 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 formula that does not have added vitamin E may be at risk for a vitamin E deficiency. Additionally, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E can treat cancer and 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. Although vitamin E is being used to try to prevent certain types of cancer, there is not enough evidence to confirm that it works.

A deficiency in vitamin E is extremely rare, except in people with conditions that prevent it from being absorbed by the body.

Vitamin E is available without a prescription.

For good health, it's important to eat a balanced and varied diet. Follow any diet plan your health care professional recommends. If you think you are not getting enough vitamins and/or minerals from your diet, you may consider taking a dietary supplement.

You can find vitamin E 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.

Taking vitamin supplements alone will not replace a healthy diet and will not give you energy. Your body also needs other nutrients found in food, such as protein, minerals, carbohydrates, and fat. Vitamins often need other food components to work properly. For example, a small amount of fat is necessary for your body to absorb vitamin E.

The daily amount of vitamin E needed is defined in a few 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 for a nutrient may vary based on age, sex, and physical condition (like pregnancy).
• Daily Values (DVs) are used on food and dietary supplement labels to show the percentage of the recommended daily amount of each nutrient that a serving provides. DV replaces the old term United States Recommended Daily Allowances (USRDAs).

• For Canada—
• Recommended Nutrient Intakes (RNIs) are used to determine how much vitamins, minerals, and protein you need for adequate nutrition and to lower the risk of chronic diseases.

Vitamin E is available in different 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 given in Units. This has changed to 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. Most products sold in stores still use Units on their labels.

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

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no reported problems in children when taking normal daily recommended amounts. If you are giving your baby an unfortified formula, check with your healthcare professional. In that case, the baby needs to get the necessary vitamins in another way. Some studies suggest that premature infants may have low levels of vitamin E. Your healthcare professional may suggest a vitamin E supplement.

Geriatric

There have been no reported problems in older adults when taking 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. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this dietary supplement, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is generally not recommended, but it may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust 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 may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. 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

Having other medical problems may affect the use of this dietary supplement. Be sure to inform your doctor if you have any other medical issues, especially:

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they 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 occur 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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