Acetaminophen/ diphenhydramine/ phenylephrine powder packet

Generic Name: acetaminophen/diphenhydramine/phenylephrine (a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin)
Brand Name: Theraflu Nighttime Severe Cough and Cold

Acetaminophen/ diphenhydramine/ phenylephrine powder packet is used for:

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

Acetaminophen/diphenhydramine/phenylephrine powder packet is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain and fever. 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 powder packet if:

  • you are allergic to any ingredient in acetaminophen/diphenhydramine/phenylephrine powder packet
  • 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, droxidopa, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • you use other medicines containing diphenhydramine, including those used on the skin or acetaminophen

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

Before using acetaminophen/ diphenhydramine/ phenylephrine powder packet:

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

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

  • 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 powder packet's side effects
  • Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of bleeding, irregular heartbeat, or heart attack may be increased
  • Beta-blockers (eg, propranolol), bromocriptine, or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by acetaminophen/diphenhydramine/phenylephrine powder packet
  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by acetaminophen/diphenhydramine/phenylephrine powder packet

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

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

  • Take acetaminophen/diphenhydramine/phenylephrine powder packet by mouth with or without food.
  • To prepare acetaminophen/diphenhydramine/phenylephrine powder packet, place the contents of one packet in a glass (8 oz/240 mL) of hot water and allow the powder to dissolve completely.
  • To prepare using a microwave, add the powder from one packet to a glass (8 oz/240 mL) of cold water, stir briskly, and then heat. Stir contents again after heating, making sure the powder has dissolved completely. Do not overheat.
  • Sip the liquid over 10 to 15 minutes while it is warm. 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 acetaminophen/diphenhydramine/phenylephrine powder packet 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 powder packet.

Important safety information:

  • Acetaminophen/diphenhydramine/phenylephrine powder packet 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 powder packet 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 powder packet; 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 powder packet without checking with your doctor.
  • Acetaminophen/diphenhydramine/phenylephrine powder packet 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.
  • 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 take more than the recommended dose without checking with your doctor.
  • Do not use acetaminophen/diphenhydramine/phenylephrine powder packet for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
  • If your symptoms do not get better in 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 powder packet 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 powder packet. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Acetaminophen/diphenhydramine/phenylephrine powder packet may harm your liver. Your risk may be greater if you drink alcohol while you are using acetaminophen/diphenhydramine/phenylephrine powder packet or if you use more than 6 packets in 24 hours. Talk to your doctor before you take acetaminophen/diphenhydramine/phenylephrine powder packet 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 powder packet 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 powder packet for a few days before the tests.
  • Tell your doctor or dentist that you take acetaminophen/diphenhydramine/phenylephrine powder packet before you receive any medical or dental care, emergency care, or surgery.
  • Use acetaminophen/diphenhydramine/phenylephrine powder packet with caution in the ELDERLY; they may be more sensitive to its effects.
  • Caution is advised when using acetaminophen/diphenhydramine/phenylephrine powder packet in CHILDREN; they may be more sensitive to its effects, especially excitability.
  • Acetaminophen/diphenhydramine/phenylephrine powder packet should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; 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 powder packet while you are pregnant. Acetaminophen/diphenhydramine/phenylephrine powder packet is found in breast milk. Do not breast-feed while taking acetaminophen/diphenhydramine/phenylephrine powder packet.

Possible side effects of acetaminophen/ diphenhydramine/ phenylephrine powder packet:

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 powder packet:

Store acetaminophen/diphenhydramine/phenylephrine powder packet at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep acetaminophen/diphenhydramine/phenylephrine powder packet out of the reach of children and away from pets.

General information:

  • If you have any questions about acetaminophen/diphenhydramine/phenylephrine powder packet, please talk with your doctor, pharmacist, or other health care provider.
  • Acetaminophen/diphenhydramine/phenylephrine powder packet 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 powder packet 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 powder packet. 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 powder packet. 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 powder packet.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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