Pseudoephedrine/ triprolidine/ dextromethorphan suspension

Generic name: pseudoephedrine/triprolidine/dextromethorphan [ SOO-doe-e-FED-rin/trye-PROE-li-deen/DEX-troe-meth-OR-fan ]
Brand name: Pediatex TDM

Pseudoephedrine/ triprolidine/ dextromethorphan suspension is used for:

Relieving symptoms of hay fever, allergies, or the common cold, including cough, nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy or watery eyes. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/triprolidine/dextromethorphan suspension is an antihistamine, decongestant, and cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use pseudoephedrine/ triprolidine/ dextromethorphan suspension if:

• you are allergic to any ingredient in pseudoephedrine/triprolidine/dextromethorphan suspension
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you are taking droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using pseudoephedrine/ triprolidine/ dextromethorphan suspension:

Some medical conditions may interact with pseudoephedrine/triprolidine/dextromethorphan suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of adrenal gland problems (eg, an adrenal gland tumor), a heart problem (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems
• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems

Some MEDICINES MAY INTERACT with pseudoephedrine/triprolidine/dextromethorphan suspension. Tell your health care provider if you are taking any other medicines, especially if any of the following apply to you:

• Digoxin or droxidopa because the risk of irregular heartbeat or a heart attack may be increased
• Beta-blockers (eg, propranolol), furazolidone, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of pseudoephedrine/triprolidine/dextromethorphan suspension's side effects
• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by pseudoephedrine/triprolidine/dextromethorphan suspension
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by pseudoephedrine/triprolidine/dextromethorphan suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if pseudoephedrine/triprolidine/dextromethorphan suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use pseudoephedrine/ triprolidine/ dextromethorphan suspension:

Use pseudoephedrine/triprolidine/dextromethorphan suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pseudoephedrine/triprolidine/dextromethorphan suspension may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of pseudoephedrine/triprolidine/dextromethorphan suspension and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use pseudoephedrine/triprolidine/dextromethorphan suspension.

Important safety information:

• Pseudoephedrine/triprolidine/dextromethorphan suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use pseudoephedrine/triprolidine/dextromethorphan suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking pseudoephedrine/triprolidine/dextromethorphan suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Avoid drinking alcohol while you are taking pseudoephedrine/triprolidine/dextromethorphan suspension.
• Do not take diet or appetite control medicines while you are taking pseudoephedrine/triprolidine/dextromethorphan suspension without checking with your doctor.
• If your symptoms do not get better within 7 days, if they get worse, or if they occur along with a fever, headache, or rash, check with your doctor.
• Diabetes patients - Pseudoephedrine/triprolidine/dextromethorphan suspension may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Pseudoephedrine/triprolidine/dextromethorphan suspension has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Do not use pseudoephedrine/triprolidine/dextromethorphan suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Do not exceed the recommended dose or take pseudoephedrine/triprolidine/dextromethorphan suspension for longer than prescribed without checking with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take pseudoephedrine/triprolidine/dextromethorphan suspension.
• Pseudoephedrine/triprolidine/dextromethorphan suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to pseudoephedrine/triprolidine/dextromethorphan suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Pseudoephedrine/triprolidine/dextromethorphan suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking pseudoephedrine/triprolidine/dextromethorphan suspension for a few days before the tests.
• Tell your doctor or dentist that you take pseudoephedrine/triprolidine/dextromethorphan suspension before you receive any medical or dental care, emergency care, or surgery.
• Use pseudoephedrine/triprolidine/dextromethorphan suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.
• Pseudoephedrine/triprolidine/dextromethorphan suspension is not recommended for use in CHILDREN younger than 6 years without first checking with your doctor.
• Caution is advised when using pseudoephedrine/triprolidine/dextromethorphan suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking pseudoephedrine/triprolidine/dextromethorphan suspension while you are pregnant. Pseudoephedrine/triprolidine/dextromethorphan suspension is found in breast milk. Do not breast-feed while taking pseudoephedrine/triprolidine/dextromethorphan suspension.

Possible side effects of pseudoephedrine/ triprolidine/ dextromethorphan suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of the mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of pseudoephedrine/triprolidine/dextromethorphan suspension:

Store pseudoephedrine/triprolidine/dextromethorphan suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep pseudoephedrine/triprolidine/dextromethorphan suspension out of the reach of children and away from pets.

General information:

• If you have any questions about pseudoephedrine/triprolidine/dextromethorphan suspension, please talk with your doctor, pharmacist, or other health care provider.
• Pseudoephedrine/triprolidine/dextromethorphan suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pseudoephedrine/triprolidine/dextromethorphan suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pseudoephedrine/triprolidine/dextromethorphan suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pseudoephedrine/triprolidine/dextromethorphan suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pseudoephedrine/triprolidine/dextromethorphan suspension.

Further information

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