CODEINE, GUAIFENESIN, AND PSEUDOEPHEDRINE

(KOE deen, gwye FEN e sin, and soo doe e FED rin) Brand: Ambifed CD, Ambifed CDX, Ambifed-G CD, Ambifed-G CDX, Biotussin DAC, Cheratussin DAC, Codafed, Codahistine Expectorant, Guaiatussin DAC, Guaifen DAC, Halotussin DAC, Lortuss EX, Maxifed CD, Maxifed CDX, Maxifed-G CD, Maxifed-G CDX, Medent C, Mytussin DAC, Nucofed Pediatric Expectorant, Phenhist Expectorant, Phenylhistine Expectorant, Suttar SF, Suttar-2, Tricode GF, Z-Tuss E

What is the most significant information I must know about codeine, guaifenesin, and pseudoephedrine?

• You must not use this medication if you have severe liver malady, inflammatory bowel malady, severe constipation, a blockage in your stomach or intestines, severe colitis or toxic megacolon, if you have a colostomy or ileostomy, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank big amounts of alcohol, or if you have a head injury or brain tumor.

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

• 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.

• Codeine may be habit-forming and should be used only by the face for whom it was prescribed. Hold the medicine in a secure seat where others can't get to it.

What is codeine, guaifenesin, and pseudoephedrine?

• Codeine is a narcotic 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.

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

• The combination of codeine, guaifenesin, and pseudoephedrine is used to treat stuffy nose, cough, sinus congestion, and chest congestion caused by allergies, the general cool, or the flu.

• Codeine, guaifenesin, and pseudoephedrine will not treat a cough that is caused by smoking, asthma, or emphysema.

• Codeine, guaifenesin, and pseudoephedrine may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking codeine, guaifenesin, and pseudoephedrine?

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

• To create certain you can safely take this medication, speak your doctor if you have any of these another conditions:

· diabetes;

· a heart rhythm disorder;

· a history of alcoholism or drug addiction;

· sleep apnea (breathing stops during sleep);

· liver or kidney disease;

· epilepsy or another seizure disorder;

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

· gallbladder disease;

· enlarged prostate or urination problems;

· an adrenal gland tumor or mess (such as Addison's disease);

· if you are dehydrated; or

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

• Codeine may be habit forming and must be used only by the face it was predesigned for. Never share this medication with other face, especially somebody with a history of drug abuse or addiction.

• FDA pregnancy category C. Codeine may reason addiction or withdrawal symptoms in a newborn if the mother takes the medicine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using the medication.

• Codeine can pass into breast milk and may harm a nursing child. The use of codeine by some nursing mothers may lead to life-threatening side effects in the child. Decongestants may also slow breast milk manufacture. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• Older adults may be more likely to have side effects from this medicine.

How must I take codeine, guaifenesin, and pseudoephedrine?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. This medication is generally taken for only 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.

• 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.

• 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 this medication within the past little days.

• Store at room temperature away from moisture and heat.

• Hold track of the amount of medication used from every new bottle. Codeine is a drug of abuse and you must be aware if anyone is using your medication improperly or without a prescription.

What happens if I miss a dose?

• Since this 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. An overdose of codeine can be fatal.

• Overdose symptoms may include confusion, extreme weakness, pinpoint pupils, cool and clammy skin, weak pulse, slow breathing, fainting, or breathing that stops.

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

What must I avoid while taking codeine, guaifenesin, and pseudoephedrine?

• Do not drink alcohol while you are taking medication that contains codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic medication.

• Ask a doctor or pharmacist till using any another cool, cough, allergy, or sleep medication. Decongestants and cough suppressants 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 a decongestant or cough suppressant.

• This medication may reason blurred vision or impair your thinking or reactions. Avoid driving or operating machinery before you know how codeine, guaifenesin, and pseudoephedrine will affect you.

What are the possible side effects of codeine, guaifenesin, and pseudoephedrine?

• 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 medicine and call your doctor at once if you have a serious side effect such as:

· quick or uneven heart rate;

· hallucinations;

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

· tremor, seizure (convulsions);

· pain or numbness in the arms or legs;

· severe stomach cramps or constipation;

· weak or shallow breathing;

· urinating smaller than normal or not at all; or

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

• Smaller serious side effects may include:

· dizziness, drowsiness;

· constipation;

· blurred vision;

· feeling nervous, restless, or anxious; or

· sleep problems (insomnia).

• 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 codeine, guaifenesin, and pseudoephedrine?

• Till using this medicine, speak your doctor if you regularly use another medicines that can create you sleepy or slow your breathing (such as cool or allergy medication, narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, and medication for seizures, depression, or anxiety).

• Speak your doctor about all another medicines you use, especially:

· alvimopan (Entereg);

· naloxone (Narcan, Suboxone);

· tramadol (Ultram, Ultracet);

· an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan, Silenor), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), fluvoxamine (Luvox), milnacipran (Savella), nortriptyline (Pamelor), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), venlafaxine (Effexor), or vilazodone (Viibryd); or

· bowel cleansing preparations (Half Lytely, Fleet Prep Kit, Evac-Q-Kwik, GoLytely, Supraprep, and others).

• This list is not complete and another drugs may interact with codeine, guaifenesin, and pseudoephedrine. 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 codeine, guaifenesin, and pseudoephedrine.

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.

(50)