Delta D3

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

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

Stop taking cholecalciferol and call your doctor at once if you have:

• thinking problems, changes in behavior, feeling irritable;

• urinating more than usual;

• chest pain, feeling short of breath; or

• early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin D is found naturally only in fish and fish-liver oils. However, it is also found in milk (vitamin D–fortified). Cooking does not affect the vitamin D in foods. Vitamin D is sometimes called the "sunshine vitamin" since it is made in your skin when you are exposed to sunlight. If you eat a balanced diet and get outside in the sunshine at least 1.5 to 2 hours a week, you should be getting all the vitamin D you need.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, fat is needed so that vitamin D can be absorbed into the body.

The daily amount of vitamin D needed is defined in several different ways.

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

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

In the past, the RDA and RNI for vitamin D have been expressed in Units (U). This term has been replaced by micrograms (mcg) of vitamin D.

Normal daily recommended intakes in mcg and Units are generally defined as follows:

Remember:

• The total amount of each vitamin that you get every day includes what you get from the foods that you eat and what you may take as a supplement.
• Your total amount should not be greater than the RDA or RNI, unless ordered by your doctor. Taking too much vitamin D over a period of time may cause harmful effects

For individuals taking vitamin D without a prescription:

• Vitamin D is stored in the body; therefore, when you take more than the body needs, it will build up in the body. This may lead to poisoning. Problems are more likely to occur in:
  • Adults taking 20,000 to 80,000 Units a day and more for several weeks or months.
  • Children taking 2,000 to 4,000 Units a day for several months.

If you are taking this medicine for a reason other than as a dietary supplement, your doctor should check your progress at regular visits to make sure that it does not cause unwanted effects.

Do not take any nonprescription (over-the-counter [OTC]) medicine or dietary supplement that contains calcium, phosphorus, or vitamin D while you are taking any of these dietary supplements unless you have been told to do so by your health care professional. The extra calcium, phosphorus, or vitamin D may increase the chance of side effects.

Do not take antacids or other medicines containing magnesium while you are taking any of these medicines. Taking these medicines together may cause unwanted effects.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Delta D3 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Delta D3. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to cholecalciferol: compounding crystal, oral capsule, oral liquid, oral solution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral wafer

Metabolic

Metabolic side effects have included hypercalcemia.[Ref]

Renal

Uncommon (0.1% to 1%): Hypercalciuria[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash, urticaria[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions such as angioedema or laryngeal edema[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting[Ref]

Some side effects of Delta D3 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.