stannous fluoride 0.63% oral care rinse - dental, Gel-Kam

Shocking Diseases of the Mouth

SIDE EFFECTS: Temporary staining of the teeth may occur. Brushing may control these stains, which can be removed by your dental professional. If this effect persists or worsens, tell your dentist or doctor promptly.Tell your dentist/doctor immediately if you notice any changes in the color or appearance of your teeth. These effects may be a result of too much fluoride.Remember that your doctor has prescribed this medication because 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.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your dentist/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 stannous fluoride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: swallowing problems (dysphagia).Children may be more sensitive to the side effects of this drug, especially if this medication is swallowed.Tell your doctor if you are pregnant before using this medication.This medication passes into breast milk. Consult your doctor before breast-feeding.

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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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