Poly-Tussin AC

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use brompheniramine, codeine, and phenylephrine in larger amounts, or for longer than prescribed. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

You should not use antihistamine medication to make a child sleepy.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than 7 days in a row. Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cough or cold medicine within the past few days.

Store at room temperature away from moisture and heat. Do not freeze.

Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Cough/cold combinations are used mainly to relieve the cough due to colds, influenza, or hay fever. They are not to be used for the chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Cough/cold combination products contain more than one ingredient. For example, some products may contain an antihistamine, a decongestant, and an analgesic, in addition to a medicine for coughing. If you are treating yourself, it is important to select a product that is best for your symptoms. Also, in general, it is best to buy a product that includes only those medicines you really need. If you have questions about which product to buy, check with your pharmacist.

Since different products contain ingredients that will have different precautions and side effects, it is important that you know the ingredients of the medicine you are taking. The different kinds of ingredients that may be found in cough/cold combinations include:

Antihistamines—Antihistamines are used to relieve or prevent the symptoms of hay fever and other types of allergy. They also help relieve some symptoms of the common cold, such as sneezing and runny nose. They work by preventing the effects of a substance called histamine, which is produced by the body. Some examples of antihistamines contained in these combinations are:

• Bromodiphenhydramine
• Brompheniramine
• Carbinoxamine
• Chlorpheniramine
• Dexchlorpheniramine
• Diphenhydramine
• Doxylamine
• Phenindamine
• Pheniramine
• Phenyltoloxamine
• Pyrilamine
• Promethazine
• Triprolidine

Decongestants—Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion. However, this effect may also increase blood pressure in patients who have high blood pressure. These include:

• Ephedrine
• Phenylephrine
• Pseudoephedrine

Antitussives—Antitussives help relieve coughing and are some contain a narcotic. These antitussives act directly on the cough center in the brain. Narcotics may become habit-forming, causing mental or physical dependence, if used for a long time. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

Narcotic antitussives
• Codeine
• Dihydrocodeine
• Hydrocodone
• Hydromorphone

Non-narcotic antitussives
• Carbetapentane
• Caramiphen
• Dextromethorphan

Expectorants—Expectorants work by loosening the mucus or phlegm in the lungs. The main expectorant used in cough and cold medicines is guaifenesin. Other ingredients added as expectorants (for example, ammonium chloride, calcium iodide, iodinated glycerol, ipecac, potassium guaiacolsulfonate, potassium iodide, and sodium citrate) have not been proven to be effective. In general, the best thing you can do to loosen mucus or phlegm is to drink plenty of water.

Analgesics—Analgesics are used in these combination medicines to help relieve the aches and pain that may occur with the common cold. These include:

• Acetaminophen
• Aspirin
• Other salicylates such as salicylamide and sodium salicylate

The use of too much acetaminophen and salicylates at the same time may cause kidney damage or cancer of the kidney or urinary bladder. This may occur if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

Anticholinergics—Anticholinergics, such as homatropine may help produce a drying effect in the nose and chest.

These cough and cold combinations are available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

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.

Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if: too much medicine is taken, it is taken in large doses, or it is taken for a long period of time.

Get emergency help immediately if any of the following symptoms of overdose occur:

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Cold, clammy skin
• confusion (severe)
• convulsions (seizures)
• drowsiness or dizziness (severe)
• nervousness or restlessness (severe)
• pinpoint pupils of eyes
• slow heartbeat
• slow or troubled breathing
• Difficulty breathing
• difficulty nursing
• increased sleepiness (more than usual)
• limpness

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling or tenderness in the upper abdomen or stomach area

• Any loss of hearing
• bloody urine
• confusion
• convulsions (seizures)
• dizziness or lightheadedness
• drowsiness (severe)
• excitement or nervousness (severe)
• fast or deep breathing
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased sweating
• nausea or vomiting (severe or continuing)
• shortness of breath or troubled breathing (for salicylamide only)
• stomach pain (severe or continuing)
• uncontrollable flapping movements of the hands, especially in elderly patients
• unusual thirst
• vision problems

• Fast, pounding, or irregular heartbeat
• headache (continuing and severe)
• nausea or vomiting (severe)
• nervousness or restlessness (severe)
• shortness of breath or troubled breathing (severe or continuing)

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin rash, hives, and/or itching

• Clumsiness or unsteadiness
• convulsions (seizures
• drowsiness (severe)
• dryness of mouth, nose, or throat (severe)
• flushing or redness of face
• hallucinations (seeing, hearing, or feeling things that are not there)
• restlessness (severe)
• shortness of breath or troubled breathing
• slow or fast heartbeat

• Headache (continuing)
• increased watering of mouth
• loss of appetite
• metallic taste
• skin rash, hives, or redness
• sore throat
• swelling of face, lips, or eyelids

• Unexplained sore throat and fever
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation
• decreased sweating
• difficult or painful urination
• dizziness or lightheadedness
• drowsiness
• dryness of mouth, nose, or throat
• false sense of well-being
• increased sensitivity of skin to sun
• nausea or vomiting
• nightmares
• stomach pain
• thickening of mucus
• trouble in sleeping
• unusual excitement, nervousness, restlessness, or irritability
• unusual tiredness or weakness

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

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.

Applies to brompheniramine / codeine / phenylephrine: oral liquid