Uses

This product is used to temporarily relieve pain from minor mouth problems (such as canker sores, sore gums/throat, mouth/gum injury). Benzocaine is a local anesthetic that works by numbing the painful area. Menthol works by providing a cooling feeling and increasing saliva in the mouth.

Do not use this product for children younger than 5 years due to risk of serious side effects. Ask your doctor for more details.

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How To Use

Read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has directed you to use this product, use it as directed.

Let the lozenge dissolve slowly in your mouth and swallow the dissolved liquid along with your saliva. Do not chew or swallow it whole.

This product is usually used every 2 hours as needed. If your doctor has directed you to use it, follow your doctor's instructions on how to use it. Do not increase your dose or use this drug more often or for longer than directed.

If you have a sore throat that is severe or that lasts more than 2 days, or a cough that lasts more than 7 days or keeps coming back, or symptoms occur with a fever, headache, rash, swelling, nausea, or vomiting, tell your doctor promptly. If sore mouth/throat or cough symptoms do not get better or last more than 7 days, see your doctor or dentist promptly. These could be signs of a serious condition. If you think you may have a serious medical problem, get medical help right away.

Side Effects

Slight burning, tingling, or stinging may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

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 product do not have serious side effects.

This product has rarely caused a very serious (possibly fatal) blood disorder (methemoglobinemia). This effect is more likely if you have breathing problems, certain diseases of the blood, or if you smoke (see also Precautions section). The symptoms of this disorder may occur within minutes to a couple of hours after using this product. Stop using this product and get medical help right away if you develop any symptoms of methemoglobinemia, including:

• pale/bluish/gray skin
• unusual tiredness
• shortness of breath
• fast heartbeat
• dizziness
• headache
• confusion

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 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 or at www.fda.gov/medwatch.

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 are allergic to benzocaine or to menthol; or to other "caine" anesthetics (such as procaine) 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 product, tell your doctor or pharmacist your medical history, especially of:

• heart disease
• certain blood disorders (G6PD deficiency, pyruvate kinase deficiency, hemoglobin-M disease, NADH-methemoglobin reductase deficiency)
• breathing problems (such as asthma, bronchitis, emphysema, smoking history)

This product may contain sugar and/or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if benzocaine passes into breast milk. Menthol passes into breast milk in small amounts. Consult your doctor 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 someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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: slow/shallow breathing, seizures, irregular heartbeat.

Notes

Keep all regular medical and lab appointments.

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. 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.