Promethazine-Phenylephrine

Warning

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Do not use this product to make a child sleepy.

This product is not recommended for use in children younger than 2 years since it might cause serious (possibly fatal) slow/shallow breathing. In children 2 years and older, carefully follow the doctor's directions to use the lowest effective dose. Do not give more often than prescribed. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients that might also affect breathing. Get immediate medical help if you notice unusual slow/shallow breathing.

Precautions

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to promethazine or phenylephrine; 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: blood/immune system problems (such as bone marrow depression), breathing problems (such as asthma, emphysema, sleep apnea), diabetes, glaucoma, heart problems (such as angina, irregular heartbeat), high blood pressure, liver problems, seizure, stomach/bowel problems (such as ulcer, blockage), overactive thyroid (hyperthyroidism), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Children should be supervised to avoid injury during bicycle riding or other possibly hazardous activities. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Liquid forms of this medication may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, 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, 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 side effects of this drug, especially slowed breathing and uncontrolled movements (See also Warning section). Young children may become excited/agitated instead of drowsy.

Older adults may be more sensitive to the effects of the drug, especially dizziness, drowsiness, confusion, constipation, trouble urinating, trouble sleeping, or fast/irregular heartbeat. Dizziness, 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. Consult your doctor before breast-feeding.

Side Effects

Drowsiness, dizziness, headache, upset stomach, nausea, constipation, or dry mouth may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: mental/mood changes (such as confusion, hallucinations), ringing in the ears, shaking (tremors), difficulty urinating, vision changes (such as blurred/double vision), easy bruising/bleeding, uncontrolled behaviors/movements (such as fixed upward stare, neck twisting, tongue movements).

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizure.

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, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

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

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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Information expires December 2024.