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|Sudal-DM Extended-Release Tablets

Sudal-DM Extended-Release Tablets

Sudal-DM Extended-Release Tablets is used for:

Temporarily relieving cough due to the common cold, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.

Sudal-DM Extended-Release Tablets is a combination of an expectorant (guaifenesin) and a cough suppressant (dextromethorphan). It works by loosening mucus and lung secretions in the chest and making coughs more productive.

Do NOT use Sudal-DM Extended-Release Tablets if:

• you are allergic to any ingredient in Sudal-DM Extended-Release Tablets
• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, selegiline) within the last 14 days
• you are taking a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine)

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

Before using Sudal-DM Extended-Release Tablets:

Some medical conditions may interact with Sudal-DM Extended-Release Tablets. Tell your health care provider 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 chronic cough, chronic bronchitis or any breathing problems, such as asthma, emphysema, or chronic obstructive pulmonary disease (COPD)
• if you have been very ill or weakened, or you are confined to a bed or chair

Some MEDICINES MAY INTERACT with Sudal-DM Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, selegiline) and SSRIs (eg, fluoxetine) because the risk of serious side effects may be increased by Sudal-DM Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sudal-DM Extended-Release 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 Sudal-DM Extended-Release Tablets:

Use Sudal-DM Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sudal-DM Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Sudal-DM Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Sudal-DM Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
• Drinking extra fluids while you are taking Sudal-DM Extended-Release Tablets is recommended. Check with your doctor for instructions.
• If you miss a dose of Sudal-DM Extended-Release Tablets and you are taking it regularly, 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.

Ask your health care provider any questions you may have about how to use Sudal-DM Extended-Release Tablets.

Important safety information:

• Sudal-DM Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sudal-DM Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Sudal-DM Extended-Release Tablets without first checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition.
• Sudal-DM Extended-Release Tablets has dextromethorphan in it. Before you start any new medicine, check the label to see if it has dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Sudal-DM Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sudal-DM Extended-Release Tablets.
• Use Sudal-DM Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• Sudal-DM Extended-Release Tablets should not be used in CHILDREN younger than 6 years 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 Sudal-DM Extended-Release Tablets while you are pregnant. It is not known if Sudal-DM Extended-Release Tablets is found in breast milk. Do not breast-feed while taking Sudal-DM Extended-Release Tablets.

Possible side effects of Sudal-DM Extended-Release 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:

Dizziness; drowsiness; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

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/findyour.htm), or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.

Store Sudal-DM Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sudal-DM Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Sudal-DM Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• Sudal-DM Extended-Release Tablets is 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 Sudal-DM Extended-Release 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.