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Chlorpheniramine/ phenylephrine/ aspirin effervescent tablets

Generic Name: chlorpheniramine/phenylephrine/aspirin (KLOR-fen-IR-a-meen/FEN-il-EF-rin/AS-pir-in)
Brand Name: Alka-Seltzer Plus Sparkling Original Cold Formula

Chlorpheniramine/ phenylephrine/ aspirin effervescent tablets is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, sneezing, sore throat, aches, and pains due to a cold. It also temporarily reduces fever. It may also be used for other conditions as determined by your doctor.

Chlorpheniramine/phenylephrine/aspirin effervescent tablets is an antihistamine, decongestant, and pain reliever/fever reducer 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 pain reliever/fever reducer works in the brain to help relieve pain and reduce fever.

Do NOT use chlorpheniramine/ phenylephrine/ aspirin effervescent tablets if:

  • you are allergic to any ingredient in chlorpheniramine/phenylephrine/aspirin effervescent tablets
  • you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen)
  • you are a child or teenager with influenza (the flu) or chickenpox, or who has received a live vaccine within the past 6 weeks
  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
  • you are taking sodium oxybate (GHB), dabigatran, or ketorolac
  • you are taking or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using chlorpheniramine/ phenylephrine/ aspirin effervescent tablets:

Some medical conditions may interact with chlorpheniramine/phenylephrine/aspirin effervescent 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 fast, slow, or irregular heartbeat
  • if you have a history of asthma; lung problems (eg, emphysema, chronic bronchitis); growths in the nose (nasal polyps); sleep apnea; bleeding or clotting problems; adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or intestines; ulcers; heartburn; upset stomach; stomach pain; trouble sleeping; trouble urinating; an enlarged prostate or other prostate problems; seizures; or thyroid problems
  • if you are on a low-salt diet or have phenylketonuria

Some MEDICINES MAY INTERACT with chlorpheniramine/phenylephrine/aspirin effervescent tablets. Tell your health care provider if you are taking any other medicines, especially any of the following

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
  • Live vaccines, especially in children and teenagers, because the risk of Reye syndrome is increased
  • Anticoagulants (eg, warfarin), clopidogrel, dabigatran, NSAIDs (eg, celecoxib, ibuprofen, ketorolac), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding may be increased
  • Insulin or oral antidiabetics (eg, glyburide, nateglinide) because the risk of their side effects, including low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating) may be increased by chlorpheniramine/phenylephrine/aspirin effervescent tablets
  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, linezolid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of chlorpheniramine/phenylephrine/aspirin effervescent tablets's side effects
  • Bromocriptine, carbonic anhydrase inhibitors (eg, acetazolamide), hydantoins (eg, phenytoin), methotrexate, or valproic acid because the risk of their side effects may be increased by chlorpheniramine/phenylephrine/aspirin effervescent tablets
  • Guanadrel, guanethidine, mecamylamine, methyldopa, probenecid, reserpine, or sulfinpyrazone because their effectiveness may be decreased by chlorpheniramine/phenylephrine/aspirin effervescent tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if chlorpheniramine/phenylephrine/aspirin effervescent 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 chlorpheniramine/ phenylephrine/ aspirin effervescent tablets:

Use chlorpheniramine/phenylephrine/aspirin effervescent tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take chlorpheniramine/phenylephrine/aspirin effervescent tablets by mouth with or without food.
  • Do not chew or swallow the tablet. Place the tablet in a glass and add 4 oz/120 mL of water. Allow the tablet to dissolve completely, then drink all of the liquid. Rinse the container with an additional small amount of water and drink the contents to ensure the entire dose is taken.
  • If you miss a dose of chlorpheniramine/phenylephrine/aspirin effervescent tablets and you are taking it on a regular schedule, 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 chlorpheniramine/phenylephrine/aspirin effervescent tablets.

Important safety information:

  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use chlorpheniramine/phenylephrine/aspirin effervescent tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using chlorpheniramine/phenylephrine/aspirin effervescent tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Talk to your doctor before you take chlorpheniramine/phenylephrine/aspirin effervescent tablets or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of chlorpheniramine/phenylephrine/aspirin effervescent tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking chlorpheniramine/phenylephrine/aspirin effervescent tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that is bloody or looks like coffee grounds; or unusual weight gain or swelling.
  • Do not take diet or appetite control medicines while you are taking chlorpheniramine/phenylephrine/aspirin effervescent tablets without checking with your doctor.
  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets has chlorpheniramine, phenylephrine, and aspirin in it. Before you start any new medicine, check the label to see if it has chlorpheniramine, phenylephrine, or aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets has sodium in it. Include this when you count your daily intake of sodium.
  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
  • Do NOT use chlorpheniramine/phenylephrine/aspirin effervescent tablets to make your child sleep.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, contact your doctor right away.
  • If your symptoms do not get better within 7 days, if they get worse, you develop new symptoms (eg, redness, swelling), or if your fever lasts more than 3 days, check with your doctor.
  • Aspirin has been linked to a serious illness called Reye syndrome. Do not give chlorpheniramine/phenylephrine/aspirin effervescent tablets to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets may decrease the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to chlorpheniramine/phenylephrine/aspirin effervescent tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking chlorpheniramine/phenylephrine/aspirin effervescent tablets for a few days before the tests.
  • Tell your doctor or dentist that you take chlorpheniramine/phenylephrine/aspirin effervescent tablets before you receive any medical or dental care, emergency care, or surgery.
  • Use chlorpheniramine/phenylephrine/aspirin effervescent tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.
  • Caution is advised when using chlorpheniramine/phenylephrine/aspirin effervescent tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Chlorpheniramine/phenylephrine/aspirin effervescent tablets should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using chlorpheniramine/phenylephrine/aspirin effervescent tablets while you are pregnant. Do not take chlorpheniramine/phenylephrine/aspirin effervescent tablets in the third trimester of pregnancy. Chlorpheniramine/phenylephrine/aspirin effervescent tablets is found in breast milk. Do not breast-feed while taking chlorpheniramine/phenylephrine/aspirin effervescent tablets.

Possible side effects of chlorpheniramine/ phenylephrine/ aspirin effervescent 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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; 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); bloody or black, tarry stools; blurred vision or other vision changes; confusion; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; heartburn; mood or mental changes; persistent trouble sleeping; restlessness; ringing in the ears or hearing loss; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain, nausea, or vomiting; tremor; unusual bruising or bleeding; vomit that is bloody or looks like coffee grounds.

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 agitation; blurred vision; confusion; hallucinations; fever; ringing in the ears or hearing loss; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe stomach pain, nausea, or vomiting; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.

Proper storage of chlorpheniramine/phenylephrine/aspirin effervescent tablets:

Store chlorpheniramine/phenylephrine/aspirin effervescent tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep chlorpheniramine/phenylephrine/aspirin effervescent tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about chlorpheniramine/phenylephrine/aspirin effervescent tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Chlorpheniramine/phenylephrine/aspirin effervescent 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 chlorpheniramine/phenylephrine/aspirin effervescent 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 chlorpheniramine/phenylephrine/aspirin effervescent tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to chlorpheniramine/phenylephrine/aspirin effervescent 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 chlorpheniramine/phenylephrine/aspirin effervescent tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
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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