When This Medicine Should Not Be Used:
You should not take this medicine if you are allergic to any of its ingredients. Talk with your doctor or pharmacist about the ingredients in the medicine you are using. You should not use this medicine if you have certain heart problems, or if you have severe high blood pressure. You should not use this medicine if you have narrow angle glaucoma, asthma, stomach ulcers, or problems urinating. You should not use this medicine if you have a breathing rate that is dangerously slow or shallow. You should not use this medicine if you are breast feeding an infant.

How to Use This Medicine:
Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• This medicine is not for long-term use.
• Drink plenty of liquids to help avoid constipation.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Make sure your doctor knows if you are using medicine to treat depression, such as amitriptyline, doxepin, or nortriptyline. Tell your doctor if you are taking phenothiazine medicine such as prochlorperazine (Compazine®), Mellaril®, Phenergan®, or Thorazine®. Phenothiazine medicine may be used to treat severe vomiting, psychiatric problems, or other conditions.
• You should not use this medicine if you are also using an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate®.
• There are many other drugs that may interact with this type of medicine. Make sure your doctor knows about all other medicines you are using.
• Do not drink alcohol while you are using this medicine. Tell your doctor if you drink alcohol on a regular basis.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding,
• Make sure your doctor knows if you have diabetes, thyroid problems, high blood pressure, heart disease, or heart rhythm problems. Tell your doctor if you have a history of kidney problems, liver problems, Addison's disease, asthma, or serious lung disease such as emphysema (COPD). Tell your doctor if you have a brain tumor, recent head injury, or a medical condition that causes increased pressure in your head (such as hydrocephalus). Make sure your doctor knows if you have prostate problems, or a narrowing or blockage of your digestive tract or urinary tract.
• Make sure your doctor knows if you have had a problem with misusing drugs in the past, or becoming dependent on drugs.
• Make sure your doctor knows if you have had an allergic reaction to codeine, hydrocodone products (such as Lortab® or Vicodin®), or to any other narcotic pain medicine. Make sure your doctor knows if you have had an allergic reaction to phenylephrine, chlorpheniramine (Chlor-Trimeton®), guiafenesin, or to any antihistamine, cough medicine, or decongestant. Tell your doctor if you cannot use medicine that contains alcohol, or if you have had trouble with constipation in the past.
• This medicine may contain phenylalanine. Make sure your doctor knows if you have phenylketonuria (PKU).
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may interact with certain drugs given during a procedure or surgery, such as anesthesia (sleeping or relaxing medicine), or pain medicine.
• This medicine may hide the warning signs of certain serious medical conditions. Do not use this medicine for a chronic (long-term) cough unless your doctor tells you to. Do not use this medicine if you are having abdominal (belly) pain, or have had a recent head injury, unless your doctor says it is OK.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• When a mother is breastfeeding and takes codeine, there is a very small chance that this medicine could cause serious side effects in the baby. This is because codeine works differently in a few women, so their breastmilk contains too much medicine. If you take codeine, be alert for these signs of overdose in your nursing baby: sleeping more than usual, trouble breastfeeding, trouble breathing, or being limp and weak. Call the baby's doctor right away if you think there is a problem. If you cannot talk to the doctor, take the baby to the emergency room or call 911.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, hallucinations (seeing things that are not there), or fainting.
• Heartbeat that is pounding or uneven.
• New or worsening fever.
• Shallow breathing.
• Sudden or severe headache.
• Trouble urinating, or feeling like you have a full bladder even after you urinate.

If you notice these less serious side effects, talk with your doctor:

• Anxiety or other mood changes that are bothersome to you.
• Blurred vision or lightheadedness.
• Cough that lasts more than one week, that, or a cough that happens with a fever, rash, or headache.
• Nausea, vomiting, stomach upset, dry mouth, or constipation.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088