Benzocaine (Oral route, oromucosal route)
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- Powder for Suspension
Uses of This Medicine:
Benzocaine is used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.
This medicine is available without a prescription. Your doctor may have special instructions on the proper use and dose for your medical problem.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Because of benzocaine's toxicity, use in children under 2 years of age is not recommended.
No information is available on the relationship of age to the effects of Cepacol® lozenges in the pediatric population. Safety and efficacy have not been established in children younger than 5 years of age.
No information is available on the relationship of age to the effects of benzocaine in geriatric patients. However, elderly patients are more likely to have blood problems (eg, methemoglobinemia), which may require caution in patients receiving benzocaine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart disease or
- Hereditary metabolic disorder affecting red blood cells (eg, G6PD deficiency, hemoglobin-M disease, NADH-methemoglobin reductase deficiency, pyruvate-kinase deficiency) or
- Lung or breathing problems (eg, asthma, bronchitis, emphysema)—Use with caution. May increase the risk of developing a serious side effect called methemoglobinemia.
- Infection in or around your mouth or
- Large sores in or around your mouth—The chance of side effects may be increased.
Proper Use of This Medicine:
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.
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.
- For oral dosage form (lozenges):
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.
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.
Precautions While Using This Medicine:
If your or your child's condition does not improve within 7 days, or if it becomes worse, check with your doctor.
After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine into his or her eyes or mouth. It can cause serious side effects, especially in children, if any of the medicine gets into the mouth or is swallowed.
This medicine may cause a rare, but serious blood problem called methemoglobinemia. This condition may occur after use of the spray for medical procedures or use of the over-the-counter gel or liquid for mouth sores or teething in children. The risk may be increased in children younger than 2 years of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Make sure you store this medicine out of reach of children. Call your doctor right away if you or your child has the following symptoms after using this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.
Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.
Make sure your doctor knows if you are also using medicines containing nitrates or nitrites. This includes nitroglycerin, Imdur®, Isordil®, Nitro-Bid®, Nitrostat®, or Transderm-Nitro®.
Side Effects of This Medicine:
- Incidence not known
- Bluish-colored lips, fingernails, or palms
- dark urine
- difficulty breathing
- dizziness or lightheadedness
- high fever
- pale skin
- rapid heart rate
- sore throat
- unusual bleeding or bruising
- unusual tiredness or weakness
- worsening of pain, redness, swelling, or irritation in or around the mouth
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:
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.
Last Updated: 6/2/2022