Consumer Information for: PMS-LIDOCAINE VISCOUS 2%

This medication is for oral topical use only.

If this medicine is recommended by your doctor, be sure to follow the directions for use that have been given. If you are treating yourself, or your child, follow the directions below. It is important to follow the instructions on how much, how to apply and, where to apply pms-LIDOCAINE VISCOUS 2%. Check with your doctor or pharmacist if you have any questions about your directions, or how to calculate or measure the correct dose amounts.

The following are general guidelines for the maximum amount of pms-LIDOCAINE VISCOUS 2% that should be used without a doctor's advice. These guidelines apply only to otherwise healthy people. If you have a special skin condition or other condition that requires a doctor's supervision, ask your doctor about the maximum amount of pms-LIDOCAINE VISCOUS 2% that you should use.

Conditions where dose adjustments may be required:

• elderly patients
• acutely ill patients
• patients with severe liver disease
• patients with severe kidney disease
• patients also treated with other anesthetics or certain antiarrhythmic drugs (such as amiodarone or mexiletine)

Usual Dose

Dose for Adults (18 Years of age and older)

• The usual effective dose for adults is 5 mL to 10 mL (1-2 measured teaspoons) at a time. Use the smallest amount needed to control your symptoms.
• Do not use this amount more than six times in a 24-hour period. Wait at least 3 hours between doses.
• The total dose for a 24-hour period should be no more than 60 mL. (12 measured teaspoons, or 4 measured tablespoons).
• Swish the appropriate amount around in your mouth to treat pain in the mouth area. To treat the throat, gargle the liquid in the back of the throat and swallow or spit the liquid out. Adults (but not children) may swallow the solution to treat the esophagus.

Dose for Children over 12 Years of Age, or younger and weighing 50 kg (110 lbs) or more

• The usual effective dose is 5 - 10 mL (1-2 measured teaspoons) at a time. Use the smallest amount needed to control the symptoms.
• Wait at least 3 hours between doses. No more than four doses should be given during a 24-hour period.
• After rinsing with the medication to treat the mouth, or gargling to treat the throat, children should not swallow the solution but spit it out.

Dose for Children 2-12 Years of Age, or older and weighing less than 50 kg (110 lbs)

• DO NOT use pms-LIDOCAINE VISCOUS 2% solution to sooth teething pain in infants or children, because serious side effects may occur.
• There may be special considerations for children under 3 years of age. DO NOT use pms-LIDOCAINE VISCOUS 2% for children in this age group without a doctor's supervision.
• The dose depends on the child's weight. Use the smallest amount possible to treat the pain. The dose should never be more than 10 ml (2 measured teaspoons) at a time.
• For each dose, use no more than 1 mL of pms-LIDOCAINE VISCOUS 2% solution per 5 kilogram (11 pounds) of the child's weight. For example, if the child weighs 25 kg (55 pounds), use a maximum of 5 ml (1 measured teaspoon) of pms-LIDOCAINE VISCOUS 2% solution per dose.
• Wait at least 3 hours between doses. No more than four doses should be given during a 24-hour period.
• Do not treat with pms-LIDOCAINE VISCOUS 2% for more than 24 hours in children under 2 years of age.
• Children should swish or gargle the solution and spit it out, not swallow it. For young children who might have trouble spitting it out, and children < 3 years of age, it should be applied with a cotton tip applicator, and only to the affected area.

Do not use more pms-LIDOCAINE VISCOUS 2%; or more often or for a longer period of time than either your doctor ordered or than these package directions recommend as this may cause unwanted side effects (see SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM).

To get the most effect from your dose of medicine:

• Shake the bottle well before using this medicine, so that you get an even dose each time you use it.
• Use only an accurate measuring device, such as a measured cup or a measured teaspoon to dose this medicine correctly.
• When used in the mouth or throat try to increase the length of time pms-LIDOCAINE VISCOUS 2% is in contact with the affected area. For example, if you are treating mouth sores, swish the liquid around in your mouth and then spit it out. For a sore throat, roll the liquid around at the back of your throat or gargle. Adults (but not children) may swallow the medicine; children should always spit it out or have the dose applied with a cotton tipped applicator.
• Do not drink water or other liquids right after you use pms-LIDOCAINE VISCOUS 2%, as this will decrease the amount of relief you get from the medicine.
• Avoid contact with your eyes.

If you are treating yourself and your condition does not seem to improve within three to five days, check with your doctor about continuing to use pms-LIDOCAINE VISCOUS 2%.

Overdose

Early signs of overdosage are numbness of the lips and around the mouth, lightheadedness, dizziness and sometimes blurred vision. In the event of a serious overdosage, trembling, seizures, and subsequently unconsciousness may occur.

If not rapidly treated, serious overdosage can lead to death. If you think you or anyone else is experiencing any of the above signs, discontinue use and get emergency help right away.