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Treating infections caused by certain bacteria.

Amoxicillin/Clavulanate Chewable Tablets are a penicillin antibiotic. It works by killing sensitive bacteria.

Do NOT use Amoxicillin/Clavulanate Chewable Tablets if:

• you are allergic to any ingredient in Amoxicillin/Clavulanate Chewable Tablets or another penicillin antibiotic (eg, ampicillin)
• you have a history of liver problems or yellowing of the eyes or skin caused by Amoxicillin/Clavulanate Chewable Tablets
• you have infectious mononucleosis (mono)
• you have recently received or will be receiving live oral typhoid vaccine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Amoxicillin/Clavulanate Chewable Tablets:

Some medical conditions may interact with Amoxicillin/Clavulanate Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of allergies, asthma, hay fever, or hives
• if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to a cephalosporin (eg, cephalexin) or another beta-lactam antibiotic (eg, imipenem)
• if you have kidney problems or gonorrhea
• if you have a history of liver problems or yellowing of the eyes or skin

Some MEDICINES MAY INTERACT with Amoxicillin/Clavulanate Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
• Probenecid because it may increase the amount of Amoxicillin/Clavulanate Chewable Tablets in your blood
• Chloramphenicol, macrolide antibiotics (eg, erythromycin), sulfonamides (eg, sulfamethoxazole), or tetracycline antibiotics (eg, doxycycline) because they may decrease Amoxicillin/Clavulanate Chewable Tablets's effectiveness
• Methotrexate because the risk of its side effects may be increased by Amoxicillin/Clavulanate Chewable Tablets
• Live oral typhoid vaccine or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Amoxicillin/Clavulanate Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amoxicillin/Clavulanate Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Amoxicillin/Clavulanate Chewable Tablets:

Use Amoxicillin/Clavulanate Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Amoxicillin/Clavulanate Chewable Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Chew Amoxicillin/Clavulanate Chewable Tablets well before swallowing.
• To clear up your infection completely, take Amoxicillin/Clavulanate Chewable Tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
• If you miss a dose of Amoxicillin/Clavulanate Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Amoxicillin/Clavulanate Chewable Tablets.

Important safety information:

• Amoxicillin/Clavulanate Chewable Tablets may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Amoxicillin/Clavulanate Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Amoxicillin/Clavulanate Chewable Tablets only works against bacteria; it does not treat viral infections (eg, the common cold).
• Be sure to use Amoxicillin/Clavulanate Chewable Tablets for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Amoxicillin/Clavulanate Chewable Tablets may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Amoxicillin/Clavulanate Chewable Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Brown, yellow, or gray tooth discoloration has occurred rarely in some patients taking Amoxicillin/Clavulanate Chewable Tablets. It occurred most often in children. The discoloration was reduced or removed by brushing or dental cleaning in most cases. Contact your doctor if you experience this effect.
• Diabetes patients - Amoxicillin/Clavulanate Chewable Tablets may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed if you use Amoxicillin/Clavulanate Chewable Tablets for a long period of time. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Amoxicillin/Clavulanate Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially patients with kidney problems.
• Use Amoxicillin/Clavulanate Chewable Tablets with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.
• Amoxicillin/Clavulanate Chewable Tablets should be used with extreme caution in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amoxicillin/Clavulanate Chewable Tablets while you are pregnant. Amoxicillin/Clavulanate Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you use Amoxicillin/Clavulanate Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Amoxicillin/Clavulanate Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; dark urine; fever, chills, or persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; stomach pain or cramps; unusual bruising or bleeding; vaginal discharge or irritation; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination; severe nausea, vomiting, or diarrhea; stomach pain; unusual drowsiness.

Store Amoxicillin/Clavulanate Chewable Tablets at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amoxicillin/Clavulanate Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Amoxicillin/Clavulanate Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Amoxicillin/Clavulanate Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Amoxicillin/Clavulanate Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.