hydrocod-cpm-PE-acetaminophen Oral

This combination product is used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Decongestants help relieve stuffy nose symptoms. This product also contains a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough. Acetaminophen (APAP) is a non-aspirin pain reliever and fever reducer. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.

How to use hydrocod-cpm-PE-acetaminophen Oral
See also Warning section.
Take this medication by mouth, usually every 4-6 hours with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs.
The dosage is based on your medical condition and response to treatment. This product contains acetaminophen. Do not take more acetaminophen than recommended. (See also Side Effects and Precautions sections.)
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking, chills, nausea, vomiting, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.
When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Inform your doctor if your condition persists or worsens.

See also Warning section.
Drowsiness, dizziness, headache, blurred vision, upset stomach, nausea, constipation, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, hallucinations), ringing in the ears, shaking (tremors), trouble urinating, weakness, easy bruising/bleeding, fast/slow/irregular heartbeat.
Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizure.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.
Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison\'s disease), certain brain disorders (e.g., head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema, sleep apnea), diabetes, a certain eye problem (glaucoma), heart problems, high blood pressure, kidney problems, liver disease, mental/mood problems (e.g., depression, psychosis), seizures, stomach/intestinal problems (e.g., ulcers, blockage), thyroid problems (e.g., hyperthyroidism, hypothyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention), use/abuse of drugs/alcohol.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcohol.
To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
The elderly may be more sensitive to the effects of this drug, especially dizziness, drowsiness, mental/mood changes, and blood pressure changes.
This product is not recommended for use in children.
During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell your doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.
This medication may pass into breast milk. Consult your doctor before breast-feeding. Products that contain codeine may rarely have undesirable effects on a nursing infant. Tell your doctor immediately if your infant develops increased sleepiness, difficulty feeding, or trouble breathing. If your product contains codeine, discuss the risks and benefits with your doctor before breast-feeding.

See also Warning section.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.
This product should not be used with the following medications because very serious (rarely fatal) interactions may occur: MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), sibutramine.
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. Avoid taking MAO inhibitors within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.
Before taking this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: other anticholinergic drugs (e.g., benztropine, belladonna alkaloids), antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), beta blockers (e.g., metoprolol, atenolol), cimetidine, guanethidine, certain inhaled anesthetics (e.g., halothane), memantine, methyldopa, narcotic antagonists (e.g., naltrexone, naloxone), reserpine, scopolamine, tricyclic antidepressants (e.g., amitriptyline, desipramine).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medications carefully to make sure you are not taking more than one product with the same ingredient(s). Consult your pharmacist if you are unsure about the ingredients in any of your medications.
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could affect your heart rate/blood pressure or cause drowsiness. Ask your pharmacist about the safe use of those products.
This medication may interfere with certain urine laboratory tests (e.g., 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: nausea, vomiting, sweating, confusion, cold/clammy skin, fast/slow/irregular heartbeat, slow/shallow breathing, seizures, loss of consciousness.

NOTES:
Do not share this medication with others. It is against the law.
Do not take this medication for several days before allergy testing because test results can be affected.

MISSED DOSE:
If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.