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Promethazine HCl and Dextromethorphan Hydrobromide Syrup

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Promethazine HCl and Dextromethorphan Hydrobromide Syrup

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Promethazine HCl and Dextromethorphan Hydrobromide Syrup Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, nausea, constipation, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

If you are very sleepy or have difficulty waking up after using this medication, stop taking this medication and talk to your doctor or pharmacist immediately. Your dosage may need to be lower.

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: decreased coordination, difficulty urinating, shaking (tremor).

Stop taking this medication and seek immediate medical attention if any of these rare but serious side effects occur: slow heartbeat, fainting, slow/shallow breathing, mental/mood changes (such as nervousness, excitement, irritability, confusion, hallucinations), abnormal/involuntary movements (such as fixed upward stare, neck twisting, tongue movements), seizures.

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Promethazine HCl and Dextromethorphan Hydrobromide Syrup (promethazine and dextromethorphan) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to promethazine or to dextromethorphan; or to any other phenothiazines (such as prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema, sleep apnea), heart problems (such as slow/irregular heartbeat, chest pain), liver problems, difficulty urinating (such as due to an enlarged prostate), stomach/bowel problems (such as blockage, ulcer), high blood pressure, diabetes, a certain eye problem (glaucoma), seizures, blood/immune system problems (such as bone marrow depression).

This drug may make you dizzy/drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. Children should be supervised to avoid injury during bicycle riding or other possibly hazardous activities.

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.

Liquid forms of this medication may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery or procedures such as X-rays with dye, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the effects of the drug, especially breathing problems such as slow/shallow breathing. Children may also experience excitability rather than drowsiness. Special caution should be taken in children with a family history of sudden infant death syndrome (SIDS), those who have a severe loss of fluid (dehydration), and those who are hard to wake up from sleep.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Promethazine HCl and Dextromethorphan Hydrobromide Syrup Consumer Overview

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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