Poly-Tussin HD

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Hydrocodone may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

You may take this medication with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• severe anxiety, confusion, fear;

• painful or difficult urination;

• little or no urinating; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• dizziness, drowsiness;

• mood changes;

• blurred vision; or

• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking chlorpheniramine, hydrocodone, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to chlorpheniramine / hydrocodone / phenylephrine: oral liquid

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• a light-headed feeling, like you might pass out;

• severe anxiety, confusion, fear;

• painful or difficult urination;

• little or no urinating; or

• dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• dizziness, drowsiness;

• mood changes;

• blurred vision; or

• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Applies to chlorpheniramine / hydrocodone / phenylephrine: oral liquid, oral syrup

Cardiovascular

Cardiovascular side effects have included hypertension, postural hypotension, tachycardia, and palpitations.[Ref]

Genitourinary

Genitourinary side effects have included ureteral spasm, spasm of vesical sphincters, and urinary retention.[Ref]

Nervous system

Nervous system side effects have included sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, and dizziness.[Ref]

Psychiatric

Psychiatric side effects have included psychic dependence and mood changes.[Ref]

Ocular

Ocular side effects have included blurred vision.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Some side effects of Poly-Tussin HD may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.