Codeine Phosphate, Phenylephrine Hydrochloride, Promethazine Hydrochloride Oral syrup

What is this medicine?

CODEINE; PHENYLEPHRINE; PROMETHAZINE (KOE deen; fen il EF rin; proe METH a zeen) is a cough suppressant, a decongestant, and an antihistamine. It helps to stop or reduce coughing and congestion of colds or allergies. This medicine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood vessel disease

• breathing problems like asthma or chronic obstructive pulmonary disease (COPD)

• drug abuse or addiction

• eczema

• glaucoma

• head injury

• heart disease

• lung or breathing disease, like asthma or chronic obstructive pulmonary disease (COPD)

• other chronic illness

• seizure disorder

• sleep apnea

• taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days

• thyroid disease

• trouble passing urine

• an allergic or unusual reaction to codeine, phenylephrine, promethazine, phenothiazines, sulfites, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take this medicine with food or milk if it upsets your stomach. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply. This medicine is not approved for use in children less than 6 years old. Certain formulations of this medicine are also not approved for use in adolescents less than 16 years old.

Patients over 65 years old may have a stronger reaction to this medicine and need smaller doses.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take extra or double doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• bromocriptine

• disopyramide

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• risperidone

• stimulant medicines for attention disorders, weight loss, or to stay awake

• thioridazine

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• atropine

• barbiturate medicines for sleep or seizures

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for Parkinson's disease like benztropine, trihexyphenidyl

• certain medicines for stomach problems like dicyclomine, hyoscyamine

• certain medicines for travel sickness like scopolamine

• ipratropium

• medicines for asthma or breathing problems

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• muscle relaxants

• narcotic medicines (opiates) for pain

• tramadol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse. If you have a high fever, skin rash, or headache, see your health care professional.

Use exactly as directed by your doctor or health care professional. Do not take more than the recommended dose. You may develop tolerance to this medicine if you take it for a long time. Tolerance means that you will get less cough relief with time. Tell your doctor or health care professional if your symptoms do not improve or if they get worse.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Children may be at higher risk for side effects.If your child has slow breathing, noisy breathing, confusion, or unusual sleepiness, stop giving this medicine and get medical help right away.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue

• anxiety, confusion, excitement, or irritable

• breathing problems

• changes in vision

• dark urine

• feeling faint or lightheaded, falls

• hallucinations

• high or low blood pressure

• irregular heartbeat

• seizure

• tremor

• trouble passing urine

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes, or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• headache

• increased sweating

• stomach upset, nausea

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This drug can be abused. Keep this medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.