Acetaminophen/ dextromethorphan/ phenylephrine packets
Generic Name: acetaminophen/dextromethorphan/phenylephrine (a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/DYE-fen-HYE-dra-meen/FEN-il-EF-rin)
Brand Name: Theraflu Severe Cold and Cough
Acetaminophen/ dextromethorphan/ phenylephrine packets are used for:
Relieving symptoms of fever, headache, minor aches and pains, sinus congestion, runny nose, sneezing, itching of the nose or throat, itchy or watery eyes, sore throat, and cough due to colds. It may also be used for other conditions as determined by your doctor.
Acetaminophen/dextromethorphan/phenylephrine packets are a decongestant, antihistamine, cough suppressant, and analgesic combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The analgesic works in the brain to decrease pain and reduce fever.
Do NOT use acetaminophen/ dextromethorphan/ phenylephrine packets if:
- you are allergic to any ingredient in acetaminophen/dextromethorphan/phenylephrine packets
- you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems
- you are unable to urinate or are having an asthma attack
- you are taking another medicine (prescription or nonprescription) that contains acetaminophen
- you are taking droxidopa or 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.
Before using acetaminophen/ dextromethorphan/ phenylephrine packets:
Some medical conditions may interact with acetaminophen/dextromethorphan/phenylephrine packets. 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 adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, the blood disease porphyria, glaucoma or increased pressure in the eye, phenylketonuria (PKU), trouble sleeping, or thyroid problems
- if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), chronic cough, or if your cough occurs with large amounts of mucus
- if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; liver problems (eg, hepatitis); an enlarged prostate or other prostate problems; or trouble urinating
- if you drink alcohol or have a history of alcohol abuse
- if you are taking medicine to treat high blood pressure
Some MEDICINES MAY INTERACT with acetaminophen/dextromethorphan/phenylephrine packets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
- Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
- Medicines that may harm the liver (eg, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
- Abiraterone, catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, linezolid, indomethacin, isoniazid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of acetaminophen/dextromethorphan/phenylephrine packets's side effects
- Beta-blockers (eg, propranolol), bromocriptine, or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by acetaminophen/dextromethorphan/phenylephrine packets
- Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by acetaminophen/dextromethorphan/phenylephrine packets
This may not be a complete list of all interactions that may occur. Ask your health care provider if acetaminophen/dextromethorphan/phenylephrine packets 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/ dextromethorphan/ phenylephrine packets:
Use acetaminophen/dextromethorphan/phenylephrine packets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take acetaminophen/dextromethorphan/phenylephrine packets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Dissolve the contents of one packet into 8 oz (240 mL) hot water. Sip the mixture while it is hot. Be sure to drink the entire mixture within 10 to 15 minutes of dissolving.
- If using a microwave, add the contents of one packet to 8 oz (240 mL) cold water. Stir before and after heating. Be sure not to overheat.
- Do not take more than 6 doses in 24 hours, unless your doctor tells you otherwise.
- If you miss a dose of acetaminophen/dextromethorphan/phenylephrine packets 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 acetaminophen/dextromethorphan/phenylephrine packets.
Important safety information:
- Acetaminophen/dextromethorphan/phenylephrine packets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use acetaminophen/dextromethorphan/phenylephrine packets 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 use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using acetaminophen/dextromethorphan/phenylephrine packets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not drink alcohol while you are using acetaminophen/dextromethorphan/phenylephrine packets.
- Do not take diet or appetite control medicines while you use acetaminophen/dextromethorphan/phenylephrine packets unless your doctor tells you otherwise.
- Acetaminophen/dextromethorphan/phenylephrine packets has acetaminophen, diphenhydramine, dextromethorphan, and phenylephrine in it. Before you start any new medicine, check the label to see if it has any of those medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Acetaminophen/dextromethorphan/phenylephrine packets may harm your liver. Your risk may be greater if you drink alcohol while you are taking acetaminophen/dextromethorphan/phenylephrine packets. Talk to your doctor before you take acetaminophen/dextromethorphan/phenylephrine packets or other fever reducers if you drink alcohol.
- 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.
- Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.
- Do not use acetaminophen/dextromethorphan/phenylephrine packets 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.
- Acetaminophen/dextromethorphan/phenylephrine packets contains phenylalanine. If you must have a diet that is low in phenylalanine, check with your doctor or pharmacist.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- If new symptoms occur; if redness or swelling is present; if cough occurs with fever, rash, or persistent headache; or if your symptoms go away and come back, do not get better within 5 to 7 days, or get worse, check with your doctor.
- If you have a sore throat that is severe; persists for more than 2 days; or occurs with fever, headache, rash, nausea, or vomiting, check with your doctor.
- Contact your doctor if you have a fever that gets worse or lasts for more than 3 days.
- Acetaminophen/dextromethorphan/phenylephrine packets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to acetaminophen/dextromethorphan/phenylephrine packets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Acetaminophen/dextromethorphan/phenylephrine packets 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/dextromethorphan/phenylephrine packets for a few days before the tests.
- Tell your doctor or dentist that you take acetaminophen/dextromethorphan/phenylephrine packets before you receive any medical or dental care, emergency care, or surgery.
- Use acetaminophen/dextromethorphan/phenylephrine packets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, nervousness, sleeplessness, and trouble urinating.
- Caution is advised when using acetaminophen/dextromethorphan/phenylephrine packets in CHILDREN; they may be more sensitive to its effects, especially excitability.
- Acetaminophen/dextromethorphan/phenylephrine packets should not be used in CHILDREN between 4 and 12 years old without first checking with the child's doctor. It should not be used in children younger than 4 years old. Discuss any questions or concerns with your doctor.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking acetaminophen/dextromethorphan/phenylephrine packets while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking acetaminophen/dextromethorphan/phenylephrine packets.
Possible side effects of acetaminophen/ dextromethorphan/ phenylephrine packets:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; nausea; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression, nervousness); seizures; severe dryness of mouth, nose, and throat; severe or persistent dizziness, drowsiness, light-headedness, or headache; severe or persistent trouble sleeping; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; trouble urinating or inability to urinate; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, blurred vision).
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; flushing, hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.Proper storage of acetaminophen/dextromethorphan/phenylephrine packets:
Store acetaminophen/dextromethorphan/phenylephrine packets 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/dextromethorphan/phenylephrine packets out of the reach of children and away from pets.
- If you have any questions about acetaminophen/dextromethorphan/phenylephrine packets, please talk with your doctor, pharmacist, or other health care provider.
- Acetaminophen/dextromethorphan/phenylephrine packets are 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/dextromethorphan/phenylephrine packets 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/dextromethorphan/phenylephrine packets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to acetaminophen/dextromethorphan/phenylephrine packets. 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/dextromethorphan/phenylephrine packets.
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.