Components:
Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 26.06.2023
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SUDATEX - DM Tablets are indicated for the temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma, particularly when these conditions are complicated with tenacious mucus and/or mucus plugs and congestion. SUDATEX - DM is effective in productive as well as nonproductive cough, but it is of particular value in dry nonproductive cough which tends to injure the mucous membrane of the air passages.
Dextromethorphan (Profen Forte DM) is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Guaifenesin (Profen Forte DM) is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Pseudoephedrine (Profen Forte DM) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Dextromethorphan (Profen Forte DM), Guaifenesin (Profen Forte DM), and Pseudoephedrine (Profen Forte DM) is a combination medicine used to treat cough, stuffy nose, sinus congestion and chest congestion caused by allergies, the common cold, or the flu.
This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.
Dextromethorphan (Profen Forte DM), Guaifenesin (Profen Forte DM), and Pseudoephedrine (Profen Forte DM) may also be used for purposes not listed in this medication guide.
Usual Adult Dose for Cough and Nasal Congestion:
Profen Forte DM 15 mg-175 mg-30 mg/5 mL oral liquid:
10 mL orally every 8 hours
Maximum dose: 30 mL daily
Profen Forte DM 15 mg-200 mg-30 mg/5 mL oral liquid:
10 mL orally every 6 hours
Maximum dose: 4 doses daily
Profen Forte DM 15 mg-400 mg-60 mg oral tablet:
1 tablet orally every 4 hours
Maximum dose: 4 tablets daily
Profen Forte DM 20 mg-400 mg-60 mg oral tablet:
1 tablet orally every 4 to 6 hours
Maximum dose: 4 tablets daily
Profen Forte DM 30 mg-400 mg-30 mg oral tablet:
1 tablet orally every 6 hours
Maximum dose: 4 tablets daily
Profen Forte DM 30 mg-400 mg-60 mg oral tablet:
1 tablet orally every 6 hours
Maximum dose: 4 tablets daily
Duration of therapy: 7 days
Usual Pediatric Dose for Cough and Nasal Congestion:
Profen Forte DM 2.5 mg-25 mg-7.5 mg/1 mL solution/drops:
2 to 5 years (24 to 47 pounds): 2 mL orally every 4 to 6 hours
Maximum dose: 4 doses daily
Profen Forte DM 15 mg-175 mg-30 mg/5 mL oral liquid:
12 years or older: 10 mL orally every 8 hours
6 to 11 years: 5 mL orally every 8 hours
Maximum dose: 3 doses daily
Profen Forte DM 15 mg-200 mg-30 mg/5 mL oral liquid:
12 years or older: 10 mL orally every 6 hours
6 to 11 years: 5 mL orally every 6 hours
Maximum dose: 4 doses daily
Profen Forte DM 15 mg-400 mg-60 mg oral tablet:
12 years or older: 1 tablet orally every 4 hours
6 to 11 years: 1/2 tablet orally every 4 hours
Maximum dose: 4 doses daily
Profen Forte DM 20 mg-400 mg-60 mg oral tablet:
12 years or older: 1 tablet orally every 4 to 6 hours
Maximum dose: 4 tablets daily
Profen Forte DM 30 mg-400 mg-30 mg oral tablet:
12 years or older: 1 tablet orally every 6 hours
Maximum dose: 4 tablets daily
Profen Forte DM 30 mg-400 mg-60 mg oral tablet:
12 years or older: 1 tablet orally every 6 hours not to exceed 4 tablets daily
6 to 11 years: ½ tablet every 6 hours
Maximum dose: 4 doses daily
Duration of therapy: 7 days
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What is the most important information I should know about Profen Forte DM?
SUDATEX - DM is contraindicated in patients with hypersensitivity to Guaifenesin (Profen Forte DM), Dextromethorphan (Profen Forte DM) Hydrobromide, or with hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and in patients on monoamine oxidase (MAO) inhibitor therapy.
Nursing Mothers: Contraindicated because of the higher than usual risk for infants from sympathomimetic amines.
Geriatric patients may be more sensitive to the effects of this medication.
Newborn or Premature Infants: SUDATEX - DM Tablets should not be administered to premature or full-term infants.
Use Profen Forte DM controlled-release and sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Profen Forte DM controlled-release and sustained-release tablets by mouth with or without food.
- Drink plenty of water while taking Profen Forte DM controlled-release and sustained-release tablets.
- Swallow Profen Forte DM controlled-release and sustained-release tablets whole. Do not break, crush, or chew before swallowing. Some brands of Profen Forte DM controlled-release and sustained-release tablets may be broken in half before they are taken. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand may be broken in half.
- If you miss a dose of Profen Forte DM controlled-release and sustained-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Profen Forte DM controlled-release and sustained-release tablets.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Cough and upper respiratory tract symptoms: Temporarily relieves nasal congestion, sneezing, nasal/throat irritation, itchy/watery eyes, and controls cough due to minor throat and bronchial irritation associated with the common cold, hay fever, or other upper respiratory allergies; helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive; reduces swelling of nasal passages.
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What other drugs will affect Profen Forte DM?
If you are taking this medication under your doctor's direction, your 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 your doctor or pharmacist first.
Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: beta blockers (e.g., metoprolol, atenolol), guanethidine, certain inhaled anesthetics (e.g., halothane), methyldopa, reserpine, tricyclic antidepressants (e.g., amitriptyline, desipramine).
Guaifenesin (Profen Forte DM) is available in both prescription and nonprescription products. Check the labels on all your medications carefully to make sure you are not taking more than one Guaifenesin (Profen Forte DM)-containing product.
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.
This medication may interfere with certain medical/laboratory tests (including urine 5-HIAA/VMA levels, brain scan for Parkinson's disease), 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.
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What are the possible side effects of Profen Forte DM?
Dizziness, headache, nausea, nervousness, or trouble sleeping may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.
If your doctor has prescribed this drug, remember that your doctor has prescribed it 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 if any of these unlikely but serious side effects occur: mental/mood changes (e.g., confusion, hallucinations), shaking (tremors), weakness.
Tell your doctor if any of these rare but very serious side effects occur: fast/slow/irregular heartbeat.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.