Hydrocodone Bitartrate, Phenylephrine Hydrochloride Oral solution

What is this medicine?

HYDROCODONE; PHENYLEPHRINE (hye droe KOE done; fen il EF rin) is a cough suppressant with a decongestant. It is used to treat the cough and congestion of colds and other respiratory infections. 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:

• drug abuse or addiction

• heart disease

• high blood pressure

• high pressure around the brain

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

• stomach or intestinal problems

• thyroid disease

• an unusual or allergic reaction to hydrocodone, phenylephrine, 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. You can take it with or without food. If it upsets your stomach, take it with food. 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 your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 years old for selected conditions, precautions do apply.

Patients over 60 years old may have a stronger reaction to this medicine.

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 double or extra doses.

What may interact with this medicine?

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

• ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine

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

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

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• barbiturates like phenobarbital

• medicines for chest pain, heart disease, high blood pressure, or heart rhythm problems

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• narcotic medicines (opiates) for pain

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• 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?

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.

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, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion, excitability, or nervousness

• fast, irregular heart rate

• feeling faint or lightheaded, falls

• high or low blood pressure

• seizure

• tremors

• trouble passing urine or change in the amount of urine

• unusually weak or tired

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

• constipation

• dizziness

• headache

• nausea, vomiting

• stomach upset

• tiredness

• 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 15 and 30 degrees C (59 and 86 degrees F).

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.