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Norel SR sustained-release tablets

Generic Name: acetaminophen/chlorpheniramine/phenylephrine/phenyltoloxamine (ah-seet-ah-MIN-oh-fen/klor-fen-EER-a-meen/fen-ill-EF-rin/fen-ill-tole-OX-a-meen)
Brand Name: Norel SR

Norel SR sustained-release tablets is used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Norel SR sustained-release tablets is an antihistamine, decongestant, and pain reliever combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion and pain associated with sinus pressure, and dries the nose and chest.

Do NOT use Norel SR sustained-release tablets if:

  • you are allergic to any ingredient in Norel SR sustained-release tablets
  • you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Norel SR sustained-release tablets:

Some medical conditions may interact with Norel SR sustained-release tablets. 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 breathing problems (eg, emphysema, asthma), heart disease, diabetes, difficulty urinating, an enlarged prostate, glaucoma, high blood pressure, an overactive thyroid, liver or kidney problems, adrenal gland problems (eg, pheochromocytoma), sleep apnea, trouble sleeping, stomach problems, urinary blockage, increased eye pressure, or viral hepatitis
  • if you regularly drink large amounts of alcohol

Some MEDICINES MAY INTERACT with Norel SR sustained-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), droxidopa, isoniazid, furazolidone, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects may be increased
  • Anticoagulants (eg, warfarin), bromocriptine, furazolidone, MAO inhibitors (eg, phenelzine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because their actions and side effects may be increased by Norel SR sustained-release tablets
  • Certain high blood pressure medicines such as beta-blockers (eg, atenolol) and guanethidine because their effectiveness may be decreased by Norel SR sustained-release tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norel SR sustained-release tablets 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 Norel SR sustained-release tablets:

Use Norel SR sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Norel SR sustained-release tablets may be taken with food if it upsets your stomach.
  • Swallow Norel SR sustained-release tablets whole. Do not break, crush, or chew before swallowing. Some brands of Norel SR sustained-release tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.
  • If you miss a dose of Norel SR sustained-release tablets and you 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 Norel SR sustained-release tablets.

Important safety information:

  • Norel SR sustained-release tablets may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Norel SR sustained-release tablets. Using Norel SR sustained-release tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Norel SR sustained-release tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • Do not exceed the recommended dose of Norel SR sustained-release tablets. Doing so will not improve your condition faster and may increase your risk for side effects.
  • If your symptoms do not improve within a few days or if they become worse, check with your doctor.
  • Norel SR sustained-release tablets contains acetaminophen and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.
  • Do not take diet or appetite control medicines while you are taking Norel SR sustained-release tablets without checking with your doctor.
  • If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Norel SR sustained-release tablets or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Norel SR sustained-release tablets may increase your risk for liver damage.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Norel SR sustained-release tablets.
  • Caution is advised when using Norel SR sustained-release tablets in the ELDERLY because they may be more sensitive to its effects.
  • Use Norel SR sustained-release tablets with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is unknown if Norel SR sustained-release tablets can cause harm to the fetus. If you become pregnant while taking Norel SR sustained-release tablets, discuss with your doctor the benefits and risks of using Norel SR sustained-release tablets during pregnancy. Some of the ingredients in Norel SR sustained-release tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Norel SR sustained-release tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Norel SR sustained-release tablets:

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:

Dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

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); chest pain; dark urine or pale stools; difficulty urinating; hallucinations; high blood pressure; rapid pulse; severe nervousness; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

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 fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of Norel SR sustained-release tablets:

Store Norel SR sustained-release tablets at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Norel SR sustained-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Norel SR sustained-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Norel SR sustained-release tablets 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 Norel SR sustained-release tablets 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 Norel SR sustained-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Norel SR sustained-release tablets. 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 Norel SR sustained-release tablets.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.

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