Chloraseptic (Oromucosal)

Phenol is used to ease pain and discomfort from sore throat, sore mouth, or canker sores.

This medicine can be bought without a prescription (OTC).

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

Call your doctor immediately if you develop a severe sore throat or a sore throat accompanied by a high fever, headache, nausea, or vomiting. These may be signs of an infection.

In deciding to use a medicine, you must 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

Inform 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 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

Appropriate studies have not been conducted on how Chloraseptic® affects children younger than 3 years of age and Ulcerease® in children younger than 4 months of age. Safety and effectiveness have not been confirmed.

Geriatric

There is no information available on how phenol affects geriatric patients.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

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.

In the U.S.

• Assure Sore Throat
• Cheracol Sore Throat
• Chloraseptic
• Chloraseptic Sore Throat
• Isodettes Sore Throat
• Oralseptic
• Osco Sore Throat
• Painalay
• Ulcerease

Available Dosage Forms:

• Spray
• Suspension

Therapeutic Class: Analgesic

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.