Phenol (oromucosal route)


    Brand Name

    US Brand Name

    Assure Sore Throat

    Cheracol Sore Throat

    Chloraseptic

    Chloraseptic Sore Throat

    Isodettes Sore Throat

    Oralseptic

    Osco Sore Throat

    Painalay

    Ulcerease


    Description

    Phenol is used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.

    This medicine is available as an over-the-counter (OTC) product.

    This product is available in the following dosage forms:

    • Spray
    • Suspension

    Before Using

    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:

    Allergies

    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.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of Chloraseptic® in children younger than 3 years of age and Ulcerease® in children younger than 4 months of age. Safety and efficacy have not been established.

    Geriatric

    No information is available on the relationship of age to the effects of phenol in geriatric patients.

    Drug Interactions

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    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.


    Proper Use

    Use this medicine exactly as directed by your doctor. Do not use more of this medicine, 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 an infection may be present.

    To use the oral rinse or spray:

    • Gargle or spray to the affected area.
    • Let the medicine remain in place for at least 15 seconds, then spit it out.

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

    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 oromucosal dosage form (spray):
        • Adults and children 3 years of age and older—One spray to the affected area every 2 hours or as directed by a doctor or dentist. Children younger than 12 years of age should be supervised while using this medicine.
        • Children younger than 3 years of age—Use and dose must be determined by your doctor.
      • For oromucosal dosage form (suspension or oral rinse):
        • Adults and children 12 years of age and older—Rinse the affected area every 2 hours or as needed. Do not use more than 12 times per day.
        • Children 4 months to 12 years of age—Apply to the affected area with a swab 6 times a day or as directed by a doctor or dentist.
        • Children younger than 4 months of age—Use and dose must be determined by your doctor.

    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.


    Precautions

    If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.

    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.


    Side Effects

    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

    • Difficulty with breathing
    • fever
    • headache
    • nausea
    • rash
    • swelling
    • 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.






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