BROMPHENIRAMINE, DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE

(brom fen EER a meen, dex tro me THOR fan, gwye FEN e sin, fen il EFF rin) Brand: AccuHist PDX Syrup, Allanhist PDX Syrup, Bromhist-PDX, EndaCof-PD

What is the most significant information I must know about this medicine?

• Do not give this medicine to a baby younger than 4 years old. Always ask a doctor till giving a cough or cool medication to a child. Death can occur from the misuse of cough and cool medicines in very young children.

• You must not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

• Do not use cough or cool medication if you have untreated or uncontrolled illness such as glaucoma, asthma or COPD, tall blood pressure, heart malady, coronary artery malady, or overactive thyroid.

• Do not use a cough or cool medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the recent 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What is brompheniramine, dextromethorphan, guaifenesin, and phenylephrine?

• Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can manufacture symptoms of sneezing, itching, watery eyes, and runny nose.

• Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

• Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

• Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can reason nasal congestion (stuffy nose).

• The combination of brompheniramine, dextromethorphan, guaifenesin, and phenylephrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, chest congestion, and sinus congestion caused by allergies, the general cool, or the flu.

• Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

• Brompheniramine, dextromethorphan, guaifenesin, and phenylephrine may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking this medicine?

• Do not use cool medication if you have untreated or uncontrolled illness such as glaucoma, asthma or COPD, tall blood pressure, heart malady, coronary artery malady, or overactive thyroid.

• Ask a doctor or pharmacist if it is safety for you to take this medication if you have:

· a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;

· diabetes;

· liver or kidney disease;

· epilepsy or another seizure disorder;

· cough with mucus, or cough caused by emphysema or chronic bronchitis;

· enlarged prostate or urination problems;

· low blood pressure;

· pheochromocytoma (an adrenal gland tumor); or

· if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

• FDA pregnancy category C. It is not known whether this medication will harm an unborn child. Do not use cough or cool medication without medical advice if you are pregnant.

• Brompheniramine, dextromethorphan, guaifenesin, and phenylephrine may pass into breast milk and may harm a nursing child. Antihistamines and decongestants may also slow breast milk manufacture. Do not use cough or cool medication without medical advice if you are breast-feeding a baby.

• Artificially sweetened cough or cool medication may contain phenylalanine. If you have phenylketonuria (PKU), check the medicine label to see if the product contains phenylalanine.

How must I take this medicine?

• Use exactly as directed on the label, or as predesigned by your doctor. Do not use in larger or less amounts or for longer than recommended. Cough or cool medication is generally taken only for a short time before your symptoms clear up.

• Do not take for longer than 7 days in a row. Conversation with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

• Measure liquid medication with a particular dose-measuring spoon or medication cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

• Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

• If you need surgery or medical trials, speak the surgeon or doctor onward of time if you have taken a cough or cool medication within the past little days.

• Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

• Since cough or cool medication is taken when needed, you may not be on a dosing schedule. If you are taking the medicine regularly, take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include severe forms of some of the side effects listed in this medicine guide.

What must I avoid while taking this medicine?

• This medicine may reason blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

• Drinking alcohol can magnify determined side effects of this medicine.

• Avoid becoming overheated or dehydrated during exercice and in hot weather. Brompheniramine can decrease sweating and you may be more prone to heat stroke.

• Ask a doctor or pharmacist till using any another cool, allergy, cough, or sleep medication. Antihistamines, antitussives, and decongestants are contained in much combination medicines. Taking determined commodity together can reason you to get too many of a determined drug. Check the label to see if a medication contains an antihistamine, antitussive, expectorant, or decongestant.

What are the possible side effects of this medicine?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Stop using this medication and call your doctor at once if you have a serious side effect such as:

· quick, slow, or uneven heart rate;

· severe dizziness or anxiety, feeling like you might pass out;

· mood changes, confusion, agitation, behavior changes, hallucinations, feelings of extreme happiness;

· severe headache, tremor, seizure (convulsions);

· light bruising or bleeding, unusual weakness;

· urinating smaller than normal or not at all;

· fever, feeling short of breath; or

· dangerously tall blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

• Smaller serious side effects may include:

· mild dizziness or drowsiness;

· mild headache;

· dry mouth, nose, or throat;

· constipation, diarrhea, upset stomach;

· blurred vision;

· sleep problems (insomnia); or

· feeling nervous, restless, anxious, or irritable.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect this medicine?

• Ask a doctor or pharmacist till using this medication if you regularly use another medicines that create you sleepy (such as narcotic pain medicine, sedatives, sleeping pills, muscle relaxers, and medication for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine.

• Ask a doctor or pharmacist if it is safety for you to use brompheniramine, dextromethorphan, guaifenesin, and phenylephrine if you are also using any of the next drugs:

· atropine (Atreza, Sal-Tropine);

· topiramate (Topamax);

· zonisamide (Zonegran);

· an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), and others;

· anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

· bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;

· bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

· irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

· ulcer medication such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

• This list is not complete and another drugs may interact with brompheniramine, dextromethorphan, guaifenesin, and phenylephrine. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine, dextromethorphan, guaifenesin, and phenylephrine.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

(10)