Monday, September 19, 2016

Phenylephrine/Brompheniramine/Dihydrocodeine Liquid


Pronunciation: FEN-il-EF-rin/BROME-fen-IR-a-meen/dye-HYE-droe-KOE-deen
Generic Name: Phenylephrine/Brompheniramine/Dihydrocodeine
Brand Name: Poly Tussin DHC


Phenylephrine/Brompheniramine/Dihydrocodeine Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory tract infections, or allergies. It may also be used for other conditions as determined by your doctor.


Phenylephrine/Brompheniramine/Dihydrocodeine Liquid is a decongestant, antihistamine, and cough suppressant 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.


Do NOT use Phenylephrine/Brompheniramine/Dihydrocodeine Liquid if:


  • you are allergic to any ingredient in Phenylephrine/Brompheniramine/Dihydrocodeine Liquid or any other codeine- or morphine-related medicine (eg, codeine, oxycodone)

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, increased pressure in the brain, or slow or shallow breathing

  • you are unable to urinate or are having an asthma attack

  • you take droxidopa, 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 Phenylephrine/Brompheniramine/Dihydrocodeine Liquid:


Some medical conditions may interact with Phenylephrine/Brompheniramine/Dihydrocodeine Liquid. 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, cor pulmonale; fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, liver problems, low blood volume, diabetes, blood vessel problems, stroke, glaucoma or increased pressure in the eye, or thyroid problems

  • if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

  • if you have severe drowsiness, a recent head or brain injury, brain tumor or lesions, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)

  • if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation, ulceration of the bowel, or diarrhea due to antibiotic use), or gallbladder problems (eg, gallstones); a blockage of your stomach, bladder, or bowel; trouble urinating; an enlarged prostate or other prostate problems; or if you have had recent stomach, bowel, or urinary surgery

  • if you have a history of alcohol abuse; drug abuse; mental or mood problems (eg, depression); or suicidal thoughts or behavior; or if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Phenylephrine/Brompheniramine/Dihydrocodeine Liquid. 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

  • Furazolidone, linezolid, or MAOIs (eg, phenelzine) because severe high blood pressure and fever may occur

  • Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur

  • Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), cimetidine, catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), HIV protease inhibitors (eg, ritonavir), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Phenylephrine/Brompheniramine/Dihydrocodeine Liquid's side effects

  • Quinidine, or rifamycins (eg, rifampin) because they may decrease Phenylephrine/Brompheniramine/Dihydrocodeine Liquid's effectiveness

  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Phenylephrine/Brompheniramine/Dihydrocodeine Liquid

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine/Brompheniramine/Dihydrocodeine Liquid

  • Naltrexone because it may decrease Phenylephrine/Brompheniramine/Dihydrocodeine Liquid's effectiveness. Withdrawal symptoms may also occur in patients who are physically dependent on opioids. Do not take naltrexone until you have stopped taking Phenylephrine/Brompheniramine/Dihydrocodeine Liquid for 7 to 10 days and you have had a negative naloxone challenge test

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine/Brompheniramine/Dihydrocodeine Liquid 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 Phenylephrine/Brompheniramine/Dihydrocodeine Liquid:


Use Phenylephrine/Brompheniramine/Dihydrocodeine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Phenylephrine/Brompheniramine/Dihydrocodeine Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Take Phenylephrine/Brompheniramine/Dihydrocodeine Liquid with a full glass of water (8 oz/240 mL).

  • Drink plenty of water while taking Phenylephrine/Brompheniramine/Dihydrocodeine Liquid.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Phenylephrine/Brompheniramine/Dihydrocodeine Liquid 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 Phenylephrine/Brompheniramine/Dihydrocodeine Liquid.



Important safety information:


  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Phenylephrine/Brompheniramine/Dihydrocodeine Liquid 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 Phenylephrine/Brompheniramine/Dihydrocodeine Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Do not take diet or appetite control medicines while you take Phenylephrine/Brompheniramine/Dihydrocodeine Liquid without checking with your doctor.

  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid has a decongestant, antihistamine, and cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not use Phenylephrine/Brompheniramine/Dihydrocodeine Liquid 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.

  • 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, if they get worse, or if they occur along with a fever, check with your doctor.

  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Phenylephrine/Brompheniramine/Dihydrocodeine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Phenylephrine/Brompheniramine/Dihydrocodeine Liquid for a few days before the tests.

  • Tell your doctor or dentist that you take Phenylephrine/Brompheniramine/Dihydrocodeine Liquid before you receive any medical or dental care, emergency care, or surgery.

  • Use Phenylephrine/Brompheniramine/Dihydrocodeine Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.

  • Caution is advised when using Phenylephrine/Brompheniramine/Dihydrocodeine Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.

  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. They may be at greater risk for severe and possibly fatal breathing problems.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine/Brompheniramine/Dihydrocodeine Liquid while you are pregnant. Phenylephrine/Brompheniramine/Dihydrocodeine Liquid is found in breast milk. Do not breast-feed while taking Phenylephrine/Brompheniramine/Dihydrocodeine Liquid.

When used for long periods of time or at high doses, Phenylephrine/Brompheniramine/Dihydrocodeine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Phenylephrine/Brompheniramine/Dihydrocodeine Liquid stops working well. Do not take more than prescribed.


Some people who use Phenylephrine/Brompheniramine/Dihydrocodeine Liquid for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.


If you suddenly stop taking Phenylephrine/Brompheniramine/Dihydrocodeine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.



Possible side effects of Phenylephrine/Brompheniramine/Dihydrocodeine Liquid:


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; dizziness; drowsiness; dry mouth, nose, or throat; 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); confusion; difficulty urinating or inability to urinate; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; persistent trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or 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; cold and clammy skin; coma; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Phenylephrine/Brompheniramine/Dihydrocodeine Liquid:

Store Phenylephrine/Brompheniramine/Dihydrocodeine Liquid 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 Phenylephrine/Brompheniramine/Dihydrocodeine Liquid out of the reach of children and away from pets.


General information:


  • If you have any questions about Phenylephrine/Brompheniramine/Dihydrocodeine Liquid, please talk with your doctor, pharmacist, or other health care provider.

  • Phenylephrine/Brompheniramine/Dihydrocodeine Liquid 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 is a summary only. It does not contain all information about Phenylephrine/Brompheniramine/Dihydrocodeine Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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