GENERIC NAME: SODIUM FLUORIDE 1.1% TOOTHPASTE - DENTAL (SOE-dee-um FLOOR-ide)
HOW TO USE: This is best used once daily just before bedtime instead of your regular toothpaste or as directed by your healthcare professional.Apply a thin ribbon of medicine to a toothbrush and brush thoroughly for 2 minutes or as directed.Spit out the medication after use. Do not swallow. Children should rinse their mouth thoroughly right away. For adults, do not rinse your mouth, eat, or drink for at least 30 minutes after use to get the best results.
SIDE EFFECTS: Mouth/gum irritation may infrequently occur. If this effect persists or worsens, tell your doctor/dentist or pharmacist promptly.Tell your doctor/dentist immediately if your teeth become stained or pitted. This is often 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, get medical help right away 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 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 sodium fluoride, tell your healthcare professional 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/dentist or pharmacist your medical history, especially of: mouth problems (e.g., sores, mucositis).Children may be more sensitive to the side effects of this drug, especially if this medication is swallowed. Watch children closely when they are using this medication to make sure that they do not swallow this medication.Before using this medicine, tell your healthcare professional if you are pregnant.It is not known if this drug passes into breast milk. Consult your healthcare professional before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, excess saliva, stomach pain, diarrhea, "coffee ground" vomit, burning sensation in the mouth or sore tongue.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from heat. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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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.