carbinoxamine, hydrocodone, and phenylephrine

Brand name(s):

carbinoxamine/hydrocodone/phenylephrine, Donatussin MAX, Excof, Excof-SF

What is the most important information I should know about carbinoxamine, hydrocodone, and phenylephrine?

Always ask a doctor before giving a cough or cold medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Do not use carbinoxamine, hydrocodone, and phenylephrine 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 carbinoxamine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Carbinoxamine, hydrocodone, and phenylephrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Do not take this product for cough caused by smoking, asthma, or emphysema. Do not take this medicine if your cough produces a lot of mucus, unless your doctor has told you to.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to 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.

What is carbinoxamine, hydrocodone, and phenylephrine?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Carbinoxamine, hydrocodone, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

This medication may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before taking carbinoxamine, hydrocodone, and phenylephrine?

Do not give this medication to a child younger than 2 years old, even if the medicine label provides dosing intructions for children in this age group. Deaths have been reported in children under 2 years old who had received carbinoxamine, although it has not been determined that carbinoxamine was the cause of these deaths. Talk with your doctor about other FDA-approved products available for use in young children with cold or allergy symptoms. Do not use carbinoxamine, hydrocodone, and phenylephrine 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 carbinoxamine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine, hydrocodone, or phenylephrine, or if you have:

a history of drug or alcohol addiction;
kidney disease;
liver disease;
diabetes;
glaucoma;
heart disease or high blood pressure;
coronary artery disease;
a stomach ulcer or an obstruction in your stomach or intestines;
an enlarged prostate or urination problems;
head injury, brain injury, or brain tumor;
Addison's disease;
thyroid problems;
emphysema or chronic bronchitis;
asthma.

If you have any of these conditions, you may not be able to take this medication, or you may require a dosage adjustment or special monitoring during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine, hydrocodone, and phenylephrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

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