Tylenol Cold Relief

Generic Name: acetaminophen/diphenhydramine (a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen)
Brand Name: Examples include Tylenol Cold Relief and Tylenol Severe Allergy

Tylenol Cold Relief is used for:

Relieving cold and flu symptoms such as minor aches and pains, fever, headache, sore throat, muscle aches, sneezing, and runny nose. It may also be used for other conditions as determined by your doctor.

Tylenol Cold Relief is an antihistamine and analgesic combination. Diphenhydramine causes drowsiness to help you fall asleep. Acetaminophen works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tylenol Cold Relief if:

  • you are allergic to any ingredient in Tylenol Cold Relief
  • you are taking sodium oxybate (GHB)

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

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Before using Tylenol Cold Relief:

Some medical conditions may interact with Tylenol Cold Relief. 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 alcoholism or if you consume 3 or more alcohol-containing drinks every day
  • if you have a fast, slow, or irregular heartbeat; liver problems (eg, hepatitis); or kidney problems
  • if you have a history of asthma; lung problems (eg, emphysema); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid

Some MEDICINES MAY INTERACT with Tylenol Cold Relief. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Furazolidone, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Tylenol Cold Relief's side effects
  • Anticoagulants (eg, warfarin) because they may increase the risk of Tylenol Cold Relief's side effects, such as bleeding
  • Beta-blockers (eg, propranolol) and hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Tylenol Cold Relief

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Cold Relief 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 Tylenol Cold Relief:

Use Tylenol Cold Relief as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Tylenol Cold Relief by mouth with or without food.
  • If you miss a dose of Tylenol Cold Relief, 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 Tylenol Cold Relief.

Important safety information:

  • Tylenol Cold Relief may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tylenol Cold Relief with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avoid alcohol while you are using Tylenol Cold Relief. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tylenol Cold Relief; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or use for longer than prescribed 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 sore throat lasts more than 2 days or fever lasts more than 3 days, or if they get worse, check with your doctor.
  • Tylenol Cold Relief may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Cold Relief. Talk to your doctor before you take Tylenol Cold Relief 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.
  • Tylenol Cold Relief has acetaminophen and diphenhydramine. Before you start any new prescription or nonprescription medicine, check the label to see if it has acetaminophen or diphenhydramine in it too. If it does or if you are not sure, contact your doctor or pharmacist.
  • Tylenol Cold Relief may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tylenol Cold Relief. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Tylenol Cold Relief may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Tylenol Cold Relief for a few days before the tests.
  • Tell your doctor or dentist that you take Tylenol Cold Relief before you receive any medical or dental care, emergency care, or surgery.
  • Use Tylenol Cold Relief with caution in the ELDERLY; they may be more sensitive to its effects.
  • Tylenol Cold Relief should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Tylenol Cold Relief 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 Tylenol Cold Relief while you are pregnant. It is not known if Tylenol Cold Relief is found in breast milk. Do not breast-feed while taking Tylenol Cold Relief.

Possible side effects of Tylenol Cold Relief:

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; headache; loss of appetite; nausea; nervousness or anxiety; 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 or pale stools; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent loss of appetite; stomach pain; tremor; trouble sleeping; unusual fatigue; vision changes; 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tylenol Cold Relief:

Store Tylenol Cold Relief 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 Tylenol Cold Relief out of the reach of children and away from pets.

General information:

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

Issue Date: April 2, 2014
Database Edition 14.2.1.001
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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