Phenylephrine Hydrochloride, Promethazine Hydrochloride Oral syrup

What is this medicine?

PHENYLEPHRINE; PROMETHAZINE (fen il EF rin; proe METH a zeen) is a decongestant and a antihistamine. It is used to treat the symptoms of allergy and colds. 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 the following conditions:

• diabetes

• enlarged prostate

• glaucoma

• heart disease

• liver disease

• seizure disorder

• serious illness

• sleep apnea

• thyroid disease

• trouble passing urine

• ulcer or other stomach problem

• an unusual or allergic reaction to 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 with a glass of water. Follow the directions on the prescription label. Use a specially marked spoon or container to measure your medicine. Household spoons are not accurate. Take your doses 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 2 years of age for selected conditions, precautions do apply. Do not use in children under 2 years old.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

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:

• bromocriptine

• cocaine

• disopyramide

• ergotamine, dihydroergotamine

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

• procarbazine

• risperidone

• stimulant drugs

This medicine may also interact with the following medications:

• alcohol

• barbiturate medicines like phenobarbital

• cabergoline

• caffeine

• diet aids

• epinephrine

• heart medicines

• linezolid

• medicines for asthma

• medicines for cold or allergies

• medicines for depression, anxiety or psychotic disturbances

• medicines for Parkinson's disease

• medicines for sleep

• medicines for the stomach like metoclopramide, dicyclomine, glycopyrrolate

• oxytocin

• pain medicines

• radio contrast dyes

• St. John's wort

• theophylline

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 if your symptoms do not improve or if they get worse.

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 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.

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.

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:

• blurred vision

• breathing trouble

• confusion

• fast, irregular heartbeat

• fever, sweating

• hallucinations

• high or low blood pressure

• lightheadedness

• muscle stiffness

• seizure

• sensitive to sunlight

• tremor, twitches

• trouble passing urine

• unusually weak

• 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

• dry mouth

• nausea, vomiting

• skin rash, itching

• stomach upset

• 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.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from light. Throw away any unused medicine after the expiration date.