Difil-G Forte

Dyphylline and guaifenesin should not be given to a child younger than 6 years old.

You should not use this medicine if you are allergic to dyphylline or guaifenesin. This medication will not treat an asthma attack.

To make sure dyphylline and guaifenesin is safe for you, tell your doctor if you have:

• heart disease or a history of heart attack;

• high blood pressure;

• liver or kidney disease;

• overactive thyroid;

• a stomach ulcer; or

• if you use a beta-blocker medicine (atenolol, bisoprolol, carvedilol, metoprolol, propranolol, sotalol, and many others).

FDA pregnancy category C. It is not known whether dyphylline and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Dyphylline and guaifenesin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Dyphylline and guaifenesin should not be given to a child younger than 6 years old.

• It is used to treat breathing problems.
• It is used to thin mucus so it can be taken from the body by coughing.
• Do not give Difil-G-Forte (dyphylline and guaifenesin liquid) to treat an asthma attack. Use a rescue inhaler. Talk with the doctor.

• If you have an allergy to this medicine or any part of Difil-G-Forte.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a cough with a lot of mucous.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Difil-G-Forte with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Restlessness.
• Upset stomach or throwing up.
• Headache.
• Loose stools (diarrhea).
• Belly pain.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Fast breathing.
• Very bad dizziness or passing out.
• Seizures.
• Throwing up blood or throw up that looks like coffee grounds.
• Blood in the urine.
• Feeling irritable.
• Feeling agitated.
• Twitching.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling nervous and excitable.
• Restlessness.
• Upset stomach or throwing up.
• Headache.
• Loose stools (diarrhea).
• Belly pain.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dyphylline is present in human milk at approximately twice the maternal plasma concentration. There are no data on the excretion of guaifenesin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.