sodium chloride solution - irrigation, Sea-Clens (cont.)

SIDE EFFECTS: If your doctor has directed you to use this product, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This solution may be absorbed into the blood, especially if it used continuously or if it stays inside your body for a long time. This absorption may cause side effects such as too much fluid in the body.Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (e.g., fever), trouble breathing, swelling, unusual weakness, mental/mood changes (e.g., restlessness, irritability).This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you have any allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain heart disease (congestive heart failure), kidney disease, swelling of the arms/legs (edema), fluid in the lungs, mineral imbalance (e.g., high sodium level).Kidney function declines as you grow older. This medication is removed by the kidneys if absorbed into the blood. Therefore, elderly people may be at greater risk for side effects if this product is absorbed into the blood.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.If you are mixing medications into this solution, check with the pharmacist to see if the medication may be used with this solution.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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