Generic Name: guaifenesin, hydrocodone, and phenylephrine (gwye FEH neh sin , high droe KOE dohn , and feh nill EH frin)Brand Names: Levall 5.0, Tussafed-HC, Tussafed-HCG
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of guaifenesin, hydrocodone, and phenylephrine is used to treat cough and nasal congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.
Guaifenesin, hydrocodone, and phenylephrine may also be used for other purposes not listed in this medication guide.What is the most important information I should know about Levall 5.0 (guaifenesin, hydrocodone, and phenylephrine)?Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Hydrocodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and phenylephrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug.What should I discuss with my healthcare provider before taking Levall 5.0 (guaifenesin, hydrocodone, and phenylephrine)?Do not use this medication if you are allergic to guaifenesin, hydrocodone, or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
Before taking guaifenesin, hydrocodone, and phenylephrine, tell your doctor if you are allergic to any drugs, or if you have:
asthma, COPD, sleep apnea, or other breathing disorders;
heart disease or high blood pressure;
a thyroid disorder;
a seizure disorder;
Addison's disease or other adrenal gland disorders;
enlarged prostate, urination problems;
mental illness; or
a history of drug or alcohol addiction.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin, hydrocodone, and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store this medicine at room temperature, away from heat, light, and moisture.
Keep track of how much of this medicine has been used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and phenylephrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or phenylephrine.
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, restless feeling, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
Less serious side effects may include:
dizziness or headache;
feeling excited or restless;
sleep problems (insomnia);
nausea, vomiting, or stomach upset;
mild loss of appetite;
warmth, tingling, or redness under your skin; or
skin rash or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.What other drugs will affect Levall 5.0 (guaifenesin, hydrocodone, and phenylephrine)?
Before taking guaifenesin, hydrocodone, and phenylephrine, tell your doctor if you are using any of the following drugs:
medicines to treat high blood pressure;
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This is not a complete list and there may be other drugs that can affect guaifenesin, hydrocodone, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.