Acetaminophen/ diphenhydramine/ phenylephrine suspension

Generic Name: acetaminophen/diphenhydramine/phenylephrine (a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin)
Brand Name: Tylenol Children's Plus Cold and Allergy

Acetaminophen/ diphenhydramine/ phenylephrine suspension is used for:

Relieving symptoms such as pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Acetaminophen/diphenhydramine/phenylephrine suspension is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use acetaminophen/ diphenhydramine/ phenylephrine suspension if:

  • you are allergic to any ingredient in acetaminophen/diphenhydramine/phenylephrine 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 take sodium oxybate (GHB) or you 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.

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Before using acetaminophen/ diphenhydramine/ phenylephrine suspension:

Some medical conditions may interact with acetaminophen/diphenhydramine/phenylephrine 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, plan 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, chronic bronchitis, emphysema); trouble breathing when you sleep (apnea): adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; the blood disease porphyria; an overactive thyroid; severe kidney problems; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with acetaminophen/diphenhydramine/phenylephrine suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Beta-blockers (eg, propranolol), catechol-o-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of acetaminophen/diphenhydramine/phenylephrine suspension's side effects
  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of bleeding, irregular heartbeat, or heart attack may be increased
  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by acetaminophen/diphenhydramine/phenylephrine suspension
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by acetaminophen/diphenhydramine/phenylephrine suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if acetaminophen/diphenhydramine/phenylephrine 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 acetaminophen/ diphenhydramine/ phenylephrine suspension:

Use acetaminophen/diphenhydramine/phenylephrine suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take acetaminophen/diphenhydramine/phenylephrine suspension by mouth with or without food.
  • Shake well before each use.
  • Use the dosing cup that comes with acetaminophen/diphenhydramine/phenylephrine suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of acetaminophen/diphenhydramine/phenylephrine suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use acetaminophen/diphenhydramine/phenylephrine suspension.

Important safety information:

  • Acetaminophen/diphenhydramine/phenylephrine suspension may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use acetaminophen/diphenhydramine/phenylephrine 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 drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using acetaminophen/diphenhydramine/phenylephrine suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do not take diet or appetite control medicines while you are taking acetaminophen/diphenhydramine/phenylephrine suspension without checking with you doctor.
  • Acetaminophen/diphenhydramine/phenylephrine suspension has acetaminophen, diphenhydramine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has these or similar medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
  • If you have a fever that becomes worse or lasts for more than 3 days, contact your doctor.
  • Contact your doctor if you have a sore throat that becomes severe, last for more than 2 days, or occurs with fever, headache, rash, nausea, or vomiting.
  • Acetaminophen/diphenhydramine/phenylephrine suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to acetaminophen/diphenhydramine/phenylephrine suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Acetaminophen/diphenhydramine/phenylephrine suspension may harm your liver. Your risk may be greater if you drink alcohol while you are using acetaminophen/diphenhydramine/phenylephrine suspension. Talk to your doctor before you take acetaminophen/diphenhydramine/phenylephrine suspension or other fever reducers if you drink more than 3 drinks with alcohol per day.
  • 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.
  • Acetaminophen/diphenhydramine/phenylephrine 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 acetaminophen/diphenhydramine/phenylephrine suspension for a few days before the tests.
  • Tell your doctor or dentist that you take acetaminophen/diphenhydramine/phenylephrine suspension before you receive any medical or dental care, emergency care, or surgery.
  • Use acetaminophen/diphenhydramine/phenylephrine suspension with caution in the ELDERLY; they may be more sensitive to its effects.
  • Caution is advised when using acetaminophen/diphenhydramine/phenylephrine suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Acetaminophen/diphenhydramine/phenylephrine suspension should not be used in CHILDREN younger than 6 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 acetaminophen/diphenhydramine/phenylephrine suspension while you are pregnant. Acetaminophen/diphenhydramine/phenylephrine suspension is found in breast milk. Do not breast-feed while taking acetaminophen/diphenhydramine/phenylephrine suspension.

Possible side effects of acetaminophen/ diphenhydramine/ phenylephrine 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; 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); dark urine; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; pale stools; seizures; severe drowsiness; severe or persistent dizziness, nervousness, lightheadedness, or headache; severe or persistent trouble sleeping; stomach pain; tremor; vision changes; yellowing of 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of acetaminophen/diphenhydramine/phenylephrine suspension:

Store acetaminophen/diphenhydramine/phenylephrine suspension at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep acetaminophen/diphenhydramine/phenylephrine suspension out of the reach of children and away from pets.

General information:

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

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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