See also Warning section.

Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as before/after surgery, motion sickness). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain opioid pain relievers (such as meperidine) work better. It may also be used for a short time to treat a runny nose due to the common cold.

Promethazine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain.

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 (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Read the Patient Information Leaflet if available from your pharmacist before you start taking promethazine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 2 to 4 times daily. For motion sickness, the first dose of promethazine should be taken 30 to 60 minutes before beginning travel. For allergies, this medication may be taken once daily at bedtime to avoid being drowsy during the day. When used before surgery, promethazine may be taken the night before or just before the procedure and may be continued afterwards as directed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your age, medical condition, and response to treatment. Children's dosage may also be based on weight. Do not increase your dose or take this medication more often than directed.

Tell your doctor if your condition does not get better or if it gets worse.

Drowsiness, dizziness, constipation, blurred vision, or dry mouth may occur. If any of these effects last or get worse, tell your doctor.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

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:

• nausea/vomiting that doesn't stop
• fainting
• slow heartbeat
• mental/mood changes (such as hallucinations, nervousness, irritability, restlessness, confusion)
• unusual/uncontrolled movements (such as fixed upward stare, neck twisting, tongue movements)
• shaking (tremor)
• difficulty urinating
• easy bleeding/bruising
• signs of infection (such as sore throat that doesn't go away, fever)
• severe stomach/abdominal pain
• yellowing eyes/skin

Get medical help right away if you have any very serious side effects, including:

• slow/shallow breathing
• 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
• 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.

See also Warning section.

Before taking promethazine, tell your doctor or pharmacist if you are allergic to it; 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, chronic obstructive pulmonary disease-COPD, sleep apnea)
• blood/immune system problems (such as bone marrow depression)
• high pressure in the eye (glaucoma)
• heart disease (such as irregular heartbeat)
• high blood pressure
• liver disease
• certain brain disorders (such as neuroleptic malignant syndrome, Reye's syndrome, seizures)
• stomach/intestine problems (such as blockage, ulcer)
• overactive thyroid (hyperthyroidism)
• difficulty urinating (for example, due to enlarged prostate)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Liquid products may contain sugar and/or alcohol. Caution is advised if you have diabetes, liver disease, 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.

Children may be more sensitive to the side effects of this drug, especially slowed breathing and uncontrolled movements (see also Warning section). This drug can often cause excitement in young children instead of drowsiness. Special care should be taken when using this medication in children who have lost a lot of fluid (dehydration), those who have a family history of sudden infant death syndrome (SIDS), 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 when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if promethazine passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)
• metoclopramide

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as some pregnancy tests, glucose tolerance test, allergy skin testing), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness/dizziness, fainting, slow/shallow breathing, seizures, muscle stiffness/twitching, widened pupils. In children, mental/mood changes (such as restlessness, irritability, hallucinations) may occur before drowsiness.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.