D2000

You should not use cholecalciferol if you have ever had an allergic reaction to vitamin D, or if you have:

• high levels of calcium in your blood (hypercalcemia);

• high levels of vitamin D in your body (hypervitaminosis D); or

• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

To make sure cholecalciferol is safe for you, tell your doctor if you have:

• heart disease;

• kidney disease; or

• an electrolyte imbalance.

Your cholecalciferol dose needs may change if you are pregnant or breast-feeding. Tell your doctor if you are pregnant or plan to become pregnant during treatment, or if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

Ask a doctor or pharmacist if it is safe for you to use cholecalciferol if you are also using any of the following drugs:

• seizure medication;

• cholestyramine, colestipol;

• steroids;

• digoxin; or

• a diuretic or "water pill."

This list is not complete. Other drugs may interact with cholecalciferol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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 D2000 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.