| Pronunciation: car bih NOX a meen, dex tro meh THOR fan, and feh nill EFF rin Brand: Dacex-A, DMax Syrup, X-Hist DM, XiraHistDM
| What is the most important information I should know about carbinoxamine, dextromethorphan, 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, dextromethorphan, 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, dextromethorphan, and phenylephrine before the MAO inhibitor has cleared from your body. |  | • | Carbinoxamine, dextromethorphan, 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. |
| What is carbinoxamine, dextromethorphan, 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. |
| • | Dextromethorphan is a 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, dextromethorphan, 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. |
| • | Carbinoxamine, dextromethorphan, and phenylephrine may also be used for purposes other than those listed in this medication guide. |
| What should I discuss with my healthcare provider before taking carbinoxamine, dextromethorphan, 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, dextromethorphan, 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, dextromethorphan, and phenylephrine before the MAO inhibitor has cleared from your body. |
| • | Before taking this medication, tell your doctor if you are allergic to carbinoxamine, dextromethorphan, or phenylephrine, or if you have: |
| · | heart disease or high blood pressure; |
| · | a stomach ulcer or a stomach obstruction, |
| · | emphysema or chronic bronchitis; or |
| · | an enlarged prostate or urination problems. |
| • | If you have any of these conditions, you may not be able to use carbinoxamine, dextromethorphan, and phenylephrine, or you may need a dosage adjustment or special tests 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, dextromethorphan, 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. |
| How should I take carbinoxamine, dextromethorphan, and phenylephrine? |
| • | Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. |  | • | Take this medicine with a full glass of water. The effervescent tablet form of this medicine must be dissolved in water. Drop the tablet into 8 ounces (1 cup) of water and allow it to dissolve. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away. |
| • | 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 where you can get one. |
| • | 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. |  | • | Store the medication at room temperature away from moisture and heat. |
| What happens if I miss a dose? |
| • | 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 the next regularly scheduled time. Do not take extra medicine to make up the missed dose. |
| What happens if I overdose? |
 | • | Seek emergency medical attention if you think you have used too much of this medicine. |
| • | Symptoms of a a carbinoxamine, dextromethorphan, and phenylephrine overdose may include confusion, blurred vision, dry mouth, nausea, vomiting, restlessness, hallucinations, fainting, and seizure (convulsions). |
| What should I avoid while taking carbinoxamine, dextromethorphan, and phenylephrine? |
| • | This medication 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. | | • | Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. |
| • | Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by carbinoxamine, dextromethorphan, and phenylephrine. |
| What are the possible side effects of carbinoxamine, dextromethorphan, and phenylephrine? |
| • | Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. | | • | Stop using this medication and call your doctor at once if you have any of these serious side effects: |
| · | feeling light-headed, fainting; |
| · | urinating less than usual or not at all; |
| · | wheezing, tightness in your chest; |
| · | fast or pounding heartbeat; or |
| · | pale skin, easy bruising or bleeding. |
| • | Continue taking this medication and talk to your doctor if you have any of these less serious side effects: |
| · | stuffy nose, chest congestion; |
| · | sleep problems (insomnia); |
| · | feeling restless or excited (especially in children); |
| • | Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. |
| What other drugs will affect carbinoxamine, dextromethorphan, and phenylephrine? |
| • | There may be other drugs that can affect carbinoxamine, dextromethorphan, 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. |
| Where can I get more information? |
| • | Your pharmacist has additional information about carbinoxamine, dextromethorphan, and phenylephrine written for health professionals that you may read. | |
