Orasol (Oral, Oromucosal)

Benzocaine is used to help relieve pain and irritation from a sore throat, sore mouth, or canker sores.

You can get this medicine without a prescription. Your doctor may have specific instructions on how to use it and what dose to take for your medical issue.

If your or your child's condition does not improve within 7 days, or if it gets worse, contact your doctor.

After using this medicine on your child's skin, closely monitor the child to ensure that none of the medicine gets into their eyes or mouth. It can cause serious side effects, especially in children, if any of the medicine enters the mouth or is swallowed.

This medicine may lead to a rare but serious blood issue called methemoglobinemia. This condition can happen after using the spray for medical procedures or the over-the-counter gel or liquid for mouth sores or teething in children. The risk may be higher in children younger than 2 years old, elderly patients, or patients with certain genetic conditions. It is more likely to occur in patients using too much of the medicine, but it can also happen with small amounts. Always keep this medicine out of reach of children. Contact your doctor immediately if you or your child experiences any of the following symptoms after using this medicine: pale, gray, or blue skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

Call your doctor right away if you develop a severe sore throat or a sore throat accompanied by a high fever, headache, nausea, or vomiting. These may indicate an infection.

Inform your doctor if you are also taking medicines that contain nitrates or nitrites. This includes nitroglycerin, Imdur®, Isordil®, Nitro-Bid®, Nitrostat®, or Transderm-Nitro®.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because benzocaine can be toxic, it is not recommended for use in children under 2 years old.

There is no information about how age affects the effects of Cepacol® lozenges in children. Safety and effectiveness have not been established in children younger than 5 years old.

Geriatric

There is no information about how age affects the effects of benzocaine in older patients. However, older patients are more likely to have blood issues (for example, methemoglobinemia), which may require caution when using benzocaine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor may want to adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Hyaluronidase
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at the same time as eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Heart disease or
• A hereditary metabolic disorder affecting red blood cells (for example, G6PD deficiency, hemoglobin-M disease, NADH-methemoglobin reductase deficiency, pyruvate-kinase deficiency) or
• Lung or breathing problems (for example, asthma, bronchitis, emphysema)—Use with caution. May increase the risk of a serious side effect called methemoglobinemia.

• An infection in or around your mouth or
• Large sores in or around your mouth—The chance of side effects may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Bluish-colored lips, fingernails, or palms
• dark urine
• difficulty breathing
• dizziness or lightheadedness
• headache
• high fever
• nausea
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• worsening of pain, redness, swelling, or irritation in or around the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Anbesol
• Babee Teething
• Benzodent
• Benz-O-Sthetic
• Bi-Zets/Benzo-Troches
• Dentemp's
• Dent-O-Kain/20
• Detane
• Gumsol
• HAD
• Hurricaine
• Hurricane Spray Kit
• Kank-A Soft Brush
• Larynex
• Miradyne-3
• Mycinette
• Orabase-B
• Oracaine
• Ora film
• Orajel
• OraMagic Plus
• Orasol
• Red Cross Canker Sore
• Thorets
• Trocaine
• Zetts
• Zilactin
• Zilactin-B

In Canada

• Anbesol Extra Strength
• Anbesol Liquid
• Baby Anbesol
• Baby Orajel
• Baby Orajel Liquid
• Maximum Strength Orajel Pm
• Orajel Extra Strength

Available Dosage Forms:

• Gel/Jelly
• Paste
• Lotion
• Spray
• Powder for Suspension
• Cream
• Swab
• Solution
• Lozenge/Troche
• Ointment

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.

Do not use this medicine for more than 2 days without checking first with your doctor.

In children, instead of using this medicine, talk with your child's doctor about different ways to treat teething. Give your child a firm rubber teething ring, or gently rub or massage your child's gums with your finger to relieve symptoms of teething pain. Do not use this medicine in children under the age of 2 unless your doctor tells you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sore throat and mouth pain: For oral dosage form (lozenges): Adults and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed. Children younger than 5 years of age—Use is not recommended. For oral dosage form (gel, spray, ointment, or solution): Adults and children 2 years of age and older—Apply to the affected area as needed. However, do not use it for more than 4 times a day. Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.