FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

Last updated on RxList: 12/8/2004

Codeine phosphate with promethazine HCl is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

The average effective dose is given in the following table (TABLE 1):

TABLE 1.

1/4 to 1/2 teaspoon (1.25 to 2.5 ml) every 4 to 6 hours,
not to exceed 7.0 ml in 24 hours.

Adults	1 teaspoon (5 ml) every 4 to 6 hours, not to exceed 30.0 ml in 24 hours.
Children 6 years to under 12 years	1/2 to 1 teaspoon (2.5 to 5 ml) every 4 to 6 hours, not to exceed 30.0 ml in 24 hours.
Children under 6 years (weight: 18 kg or 40 lbs)	1/4 to 1/2 teaspoon (1.25 to 2.5 ml) every 4 to 6 hours, not to exceed 9.0 ml in 24 hours.
Children under 6 years (weight: 16 kg or 35 lbs)	1/4 to 1/2 teaspoon (1.25 to 2.5 ml) every 4 to 6 hours, not to exceed 8.0 ml in 24 hours.
Children under 6 years (weight: 14 kg or 30 lbs)
Children under 6 years (weight: 12 kg or 25 lbs)	1/4 to 1/2 teaspoon (1.25 to 2.5 ml) every 4 to 6 hours, not to exceed 6.0 ml in 24 hours.

Codeine phosphate with promethazine HCl is not recommended for children under 2 years of age.

Storage: Keep bottles tightly closed—store at room temperature, between 15-25°C (59-77°F).

Protect from light.

Dispense in light-resistant, glass, tight containers.

Last updated on RxList: 12/8/2004

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

Last updated on RxList: 12/8/2004

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

Last updated on RxList: 12/8/2004

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

Last updated on RxList: 12/8/2004

No information provided.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

Last updated on RxList: 12/8/2004

Codeine phosphate; promethazine is used for the temporary relief of coughs and upper respiratory symptoms associated with an allergy or the common cold. Notify your physician if you are pregnant or nursing. Do not take this medication with monoamine oxidase inhibitors. This medication may cause dizziness, drowsiness, or blurred vision; use caution while driving or operating hazardous machinery. Do not take any other sedating drugs or drink alcohol while taking codeine with promethazine. This medication may be habit forming. Withdrawal symptoms may occur after you stop taking it. May cause nausea, vomiting or constipation; notify your physician if these occur. Notify physician if you develop muscle spasms, uncontrolled twitching in the face and body, or uncontrolled tongue or jaw movements. This medication may cause increased sensitivity to sunlight. Use sunscreens and wear protective clothing until degree of sensitivity is determined. This medication may be taken with food to avoid stomach upset.

FOR COMPLETE PRESCRIBING INFORMATION, REFER TO THE INDIVIDUAL DRUG MONOGRAPHS CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PROMETHAZINE/CODEINE SYRUP - ORAL

(pro-METH-uh-zeen/KO-deen)

COMMON BRAND NAME(S): Phenergan w/ codeine

WARNING: The promethazine in this combination medication should not be used in children younger than 2 years due to an increased risk for serious (rarely fatal) slow/shallow breathing (respiratory depression). This infrequent side effect may occur even with usual prescribed doses of promethazine. The lowest effective dose should be used, and other drugs that may slow down breathing should be avoided. Some manufacturers recommend that promethazine and other drugs that may also slow down breathing (e.g., the codeine in this product) should not be used together in children younger than 16 years. Seek immediate medical attention if you notice symptoms of slow/shallow breathing.

USES: This combination medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (e.g., sinusitis, bronchitis). Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Codeine is a narcotic cough suppressant (antitussive) that affects a certain part of the brain, reducing the urge to cough.

HOW TO USE: Take this medication by mouth with or without food, usually every 4 to 6 hours as needed with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication can be taken with food if stomach upset occurs. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor.

Use a medication-measuring device to carefully measure the prescribed dose. Do not use a household spoon. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.

This medication may cause dependence, especially if it has been used regularly for an extended time (more than a few weeks) or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include anxiety, restlessness, sweating, shaking chills, nausea, vomiting, and diarrhea. Report any such reactions to your doctor immediately. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.

SIDE EFFECTS: Drowsiness, dizziness, headache, lightheadedness, blurred vision, upset stomach, nausea, constipation, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: involuntary behaviors/movements (e.g., fixed upward stare, neck twisting, tongue movements), mental/mood changes (e.g., confusion, hallucinations), ringing in the ears, shaking (tremors), slow/shallow breathing, trouble urinating, weakness.

Seek immediate medical attention if any of these rare but very serious side effects occur: dark urine, easy bruising/bleeding, slow heartbeat, persistent nausea/vomiting, severe abdominal pain, yellowing eyes/skin.

This drug may infrequently cause a very serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). If you notice any of the following unlikely but very serious side effects, stop taking this medication and seek immediate medical attention: fast/irregular heartbeat, very high fever, mental/mood changes (e.g., confusion, extreme drowsiness), seizure, severe muscle stiffness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other side effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

This medication should not be used in a person who is unconscious or has severe breathing problems (e.g., respiratory depression, hypercapnia).

Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., morphine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison's disease), blood/immune system problems (e.g., bone marrow depression), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), diabetes, glaucoma, heart problems (e.g., angina, irregular heartbeat), high blood pressure, liver disease, mental/mood problems (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., ulcers, blockage), thyroid disease, trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit the use of alcohol and certain other medications that cause drowsiness (see also Drug Interactions). To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.

The elderly may be more sensitive to the effects of this drug, especially dizziness, drowsiness, mental/mood changes, and low blood pressure.

During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell your doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk and have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: epinephrine for low blood pressure, metrizamide, sibutramine.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic drugs (e.g., benztropine, belladonna alkaloids), cancer chemotherapy (e.g., methotrexate), cimetidine, guanethidine, guanadrel, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), narcotic antagonists (e.g., naltrexone, naloxone), quinidine.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Also report the use of drugs that might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

This medication may interfere with certain laboratory tests (e.g., some pregnancy tests, blood sugar tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, cold/clammy skin, fast/slow/irregular heartbeat, slow/shallow breathing, seizures, fainting.

NOTES: Do not share this medication with others. It is against the law.

Do not take this medication for several days before allergy testing because test results can be affected.

MISSED DOSE: If you are prescribed this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in a tightly closed container at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.